Sourced from ClassicSleepCare –
One of the unique, if not peculiar aspects of managing patients on PAP therapy is that no standard model of medical care exactly matches our unusual and perceived as cumbersome or invasive treatment modality. Previously, we have talked about the common comparison of adjusting the dosage of a medication, as in the example of a diabetic or someone with depression who might need repeated medical visits, especially in the early stages of finding the right medication while concurrently fine tuning the dosage of the medication(s). Various steps often include the timing, the frequency of medication use, the amount of medicine, the variance of amount of medicine by time of day or other circumstances tailored to the individual patient, and of course the predictability of side-effects and how to take steps to prevent or overcome them. Such a process is usually called “medical management” of a disease process, and for the most part requires the doctor and patient to meet in person or talk by phone or through other means of personal communication.
PAP therapy has some of these elements, and we often start with preventing or overcoming side effects due to mask issues, which over time might require repeated encounters with the DME staff, sleep center staff or the sleep specialist. In some situations, early and aggressive follow-up might overcome mask issues and give the patient sufficient confidence to forge ahead into the territory of regular use or as the insurance companies call it, “compliance” or “adherence.” Yet, even these encounters are quite different than most medical management appointments, because the physician may never need to lay hands on the patient to treat diabetes or depression, other than to perform a cursory and sometimes irrelevant physical examination. The discussion between doctor and patient leads the physician or other prescribing provider to make the appropriate adjustments. Whereas, in the vast majority of medical encounters for mask adjustments, the sleep tech or sleep specialist are manipulating elements such as various masks styles, chinstraps, mask liners and so forth. And, if the sleep professional is not skilled in working manually in this way and simply imagines the process can be talked through, the outcomes are usually far worse than if someone is literally placing the mask on the patient’s face and then having the patient demonstrate efficacy via repeated re-fittings.
So, to be clear, dealing with PAP obviously has a lot more hands-on to it than traditional medical management, and I would offer that a closer and more accurate analogy might be medical procedures or therapies that involve more invasive or at least hands-on medical encounters. One of the most common medical visits of this type would fall into the category of physical therapy, where the individual is recovering from surgery or an injury, or they may be suffering from chronic pain or range of motion problem. In this area, it is rare to see the physical therapist one time. Rather, there is a stepwise process, combining analysis and instruction, after which the patients does his “homework” and practices the manipulations, stretches, or other strengthening steps and then reports back to the therapist. The PT then re-analyzes the progress and subsequently adjusts or fine tunes the instructions. This process unfolds as often as twice or even three times per week depending upon the severity of the condition. Over time, it drops down to once per week and then twice per month, but it would be unusual for the treatment manipulations to not continue for weeks or months on end until the optimal response was achieved.
We can examine other medical interventions on a spectrum from somewhat invasive to highly invasive. Akin to physical therapy, many patients with aches and pains or musculo-skeletal problems make regular use of chiropractic services. Another area of interest would be orthodontics, a process that frequently requires one to two years of intervention, and during which repeated adjustments are required either to alleviate painful side-effects or to promote the corrective dental shaping of the upper and lower arches. Still more invasive would be cardiovascular procedures, and the two most obvious would be the implantation of pacemakers to protect against dangerous arrhythmias or the use of electrophysiology intervention studies (EPS) to eliminate arrhythmias altogether.
The course of EPS treatment for arrhythmias is similar to failed CPAP treatment, because we know that EPS often eliminates atrial fibrillation in the early post-procedure period, only to have the arrhythmia return in as a little as a few days to a few months. In fact, looking at a PubMed search, there are nearly 1000 articles on the problem of early recurrence (ER) of atrial fibrillation, which is just one of the arrhythmias treated with EPS. The similarity here is that a huge number of CPAP patients often report a great response initially but within a matter of weeks or months, they then notice a steady decline, which leads them to believe either something must be wrong with the machine or perhaps they’ve been given the wrong treatment altogether. In the case of a failed EPS treatment where the atrial fibrillation returns, it is not an automatic return trip to the catheterization lab (see more here to learn about EPS studies). However, a return to the cath lab does occur for many patients, because the technology is so advanced there is a very good chance to achieve a successful and more lasting outcome.
If you can imagine the basics of an EPS study, a catheter with special sensors on the end is inserted through a large vein in the body and threaded all the way into the heart chambers to map out areas where the heart’s electrical signals control the beating of the muscle. A regular rhythm (known as normal sinus rhythm) can easily be observed on a simple EKG, but if a patient develops an arrhythmia, the EPS technology can determine whether or not an area of affected heart muscle can be “treated” (ablated) in such a way to prevent the irregularity in the heart’s electrical signals. While there may be certain risks involved in the procedure, cardiologists will often discuss the value of a return trip to the cath lab in a patient with ER (early recurrence of atrial fibrillation after the first ablation study). Usually, a patient is motivated to move forward with the 2nd study, because not only has the problem of atrial fibrillation returned but also all the associated symptoms such as fatigue, low energy, dizziness and worse may re-emerge as the heart can no longer pump the blood consistently due to the irregular rhythm.
Just so with OSA/UARS, a person may or may not receive early benefits, but regardless most patients undergo at least one follow-up encounter through the DME or the sleep center where a poor responder is likely to complain about the lack of benefits.
What should be done in this situation varies across sleep centers and DME companies, but the general perspective held by the vast majority of sleep professionals is to work through daytime appointments to correct assorted issues. The most common ones might be mask leak, mouth breathing, mask pain, mask discomfort, skin irritation or the big one of pressures feeling too high or too forceful. What’s ironic about these scenarios is the belief that the technology only needs to be corrected in hands-on ways that do not rely on precise quantitative means. In other words, take the example of mask leak, suppose a sleep tech or a DME staff changes the mask on a patient. Logically, we would expect there to be a testing of the change. Yet, many facilities do not arrange for the patient to lie down in a sleeping position, position the new mask and then turn on the pressure so that the elimination of leak can be confirmed. Instead, it’s all on the patient to go home and sort out the leak issue through additional trial and error.
Even if we accept the assumption that it’s costly to return someone to the sleep lab for EF (early failure) due to mask leak, we should all be capable of appreciating that bringing the patient back to the sleep lab is the most accurate way to measure the changes in leak with a new mask. And, most importantly, throughout the night for the duration of the study, the mask leak can be monitored every step of way in NREM or REM sleep, in supine or prone sleep, on left-sided or right-sided sleep, and even when the patient is awake or sleep, or having leg jerks or not having leg jerks and so on.
This accuracy is exactly what you would expect for an EPS study, and it’s exactly what you get. An EPS is arguably a more advanced and delicate procedure, and as such we are not surprised that it may cost several thousand dollars, while lasting anywhere from one to a few hours. A sleep study lasts the whole night, and in most areas of the country, we would be lucky to get a thousand dollars for a study. Setting price aside, though, the real issue is whether or not a sleep apnea patient has the right to expect greater precision in treatment options?
This point is key because the movement continues to build towards preventing patients from ever visiting the sleep lab for an overnight study. In my travels, and most notably on the east coast, I meet many individuals with OSA who have never been in a sleep lab despite struggling with CPAP devices for months or years. Indeed, many report they were unaware of such an option. They are told to accept the system that says use an APAP mode, and the only followup permitted is the tweaking of settings that might occur based on changes in outcomes or lack thereof.
Each of the additional items listed above, including mouth breathing, mask pain, mask discomfort, skin irritation or the big one of pressures feeling too high or too forceful, are all managed in the same way in the conventional wisdom approach to sleep medicine care. Instead of precision responses to rectify the problems, the patient receives hands-on responses without any of the sophisticated measuring capabilities of the sleep lab. The silliest of these misadventures occurs with mouth breathing, because it is nearly impossible to detect the extent and impact of mouth breathing without observing the problem first-hand in the sleep lab. Even then, some sleep professionals teach their sleep techs to avoid entering the bedroom for fear of waking the patient. Yet, the only way to observe mouth breathing accurately is by having the sleep tech quietly step into the bedroom.
When a tech observes mouth breathing, all sorts of details can be reported, many of which subsequently lead to more precise adjustments. Is it positional (e.g. supine), due to a certain stage of sleep (e.g. REM), related to mask slippage, related to wrong mask, related to wrong size mask, or does it emerge directly after a leg jerk? In other words, lots of highly accurate and precise information can be garnered by the direct efforts of a sleep tech watching the process, akin at some level to an interventional cardiologist attempting to map out the damaged cardiac muscle causing the arrhythmia.
PAP pressures are the ultimate in direct hands-on fine tuning, and the results are often dramatic when a patient is properly titrated to effectively round both the inspiratory and the expiratory limbs of the airflow curve. It is virtually impossible at least in any sense of timeliness to discover the optimal pressure settings by trial and error at home. No doubt settings can be moved in the right direction that fosters improved outcomes, but this process does not attempt or even acknowledge the potentiality of a completely normalized breathing pattern. As with an EPS study that would seek to eliminate (ablate or deactivate) all cardiac tissue that triggers atrial fibrillation, the end result would be normal sinus rhythm all the time or as much of the time as possible. Normal sinus rhythm generally speaking shows a consistent pattern, although other components of heart disease may affect the shape of the heart tracing.
When we approach the problem of normalized airflow during sleep, we presume this target is the most appropriate pathway forward, despite the conventional wisdom from the American Academy of Sleep Medicine that only mandates the elimination of breathing events without ever itemizing what it means to normalize the airflow curve.
In terms of medical seriousness (our ultimate way of comparing two different diseases), there are many consequences caused by untreated atrial fibrillation as well as from many other cardiac arrhythmias. Some of these adverse effects lead to serious health problems and sometimes mortality. Though many specialists in sleep medicine tend to be shy about equating the seriousness of sleep health to the seriousness of heart health, inadequate treatment of OSA/UARS is a very serious problem that largely goes unrecognized or is routinely underestimated by many medical professionals throughout numerous non-sleep related fields of medicine. Some of the more common fields that ignore this perspective would be psychiatrists and other therapists in evaluating treatment resistance in several mental health disorders, urologists in assessment and treatment of nocturia, nephrologists in managing chronic renal failure, and even some cardiologists in managing assorted cardiovascular conditions.
Upon examination of the field of sleep medicine, as written about in prior posts on this blog, it is a very serious matter when the airflow signal is not properly normalized for much of the night, because the individual could experience additional trips to the bathroom, thus increasing risks for falls during the night. If a patient has dropped their trips to the bathroom from three per night to two on an APAP device while using its default pressure settings, why wouldn’t sleep professionals want to explore the possibility of dropping the trips to the bathroom down to once per night or not at all? Not only do most sleep specialists ignore this possibility, that is, they refuse to place their patients in the sleep lab to fully normalize the airflow signal with the optimal pressure settings, but also, they may be ignorant of the fact that nocturia (trips to the bathroom at night) may be decreased further or eliminated entirely just by making further treatment gains in the management of sleep-disordered breathing.
Sadly, I have had this conversation on these specific points with a number of sleep professionals, including physicians and sleep technologists. Most of them buy into the conventional wisdom that since everyone seems to go to the bathroom at night, it’s probably normal to go once or twice. By embracing this conventional wisdom, the medical provider does the patient a great disservice by assuming nocturia is not directly related to OSA/UARS.
We discovered the deeper connection between normalized airflow and elimination of nocturia in our quest to understand why fixed pressure CPAP was not providing excellent to outstanding responses in our patients. When we first made the switch to BPAP in 2005 and learned about the possibility of normalizing the airflow curve, the patients reported greater improvements in daytime sleepiness and fatigue as well as fewer episodes of nocturia. As we continued in advancing our systems to ABPAP in 2008 and then ASV in 2010, we saw that persistent, aggressive attempts to normalize the airflow curve led to greater improvements in sleepiness and fatigue and fewer nocturia trips.
The most surprising and alarming aspect of our findings is the pervasive lack of curiosity among other sleep physicians to at least become somewhat curious as to why so many patients fail CPAP. It appears that many sleep professionals simply accept CPAP failure is par for the course. Because technological advances with PAP are not routinely studied in research investigations, and because the research is almost never conducted to manually titrate these advanced devices in the sleep lab, our field has been stuck in first gear for decades, searching for CPAP failure factors everywhere but inside the sleep lab.
Forgive me if I offered this old Sufi adage previously about the Nasrudin character who comes upon a man searching frantically for his keys outside his home. After Nasrudin joins the search, but to no avail, he asks the man, “do you recall where you lost the keys?” The man responds “inside my house.” A perplexed Nasrudin queries him back, “So, why are we looking out here?” To which the senseless man replies, “because there’s more light.”
This lack of curiosity is literally causing a great deal of morbidity and mortality among sleep patients, because they go untreated for failing to be able to use CPAP or using it but failing to gain notable benefits from it. And, instead of their sleep physicians acting in accordance with how a cardiologist evaluates and treats the re-emergence of atrial fibrillation after an EPS study, the typical OSA/UARS patient receives no such support.
So, let us be very clear again on what these points mean. If patients are suffering from poorly controlled hypertension and are failing CPAP, then everything points to the facts that they have greater risks for strokes, heart attacks and other cardiovascular events. If such patients are already on multiple medications for hypertension and still suffering from poor control, then failing CPAP puts them at still greater risk, because their medical management appears to be maxed out. Some of these patients will die, some will suffer heart attacks and some will suffer strokes. All these patients might have had a second or third chance if they were permitted to visit or return to the sleep lab (the latter if they were lucky enough to start off on in the sleep lab), during which they could receive the same degree of precise care as a cardiologist working with a case of a failed EPS study. By normalizing the airflow curve with precision techniques, some of these patients would adapt to advanced PAP; and, in becoming regular users they would most likely experience greater control of their blood pressure, all of which would decrease their risks for other unhealthy outcomes.
The above paragraph could be repeated nearly verbatim for elderly people with nocturia, a leading if not the leading cause of falls, broken hips, and potentially mortality in this population. When their sleep facilities do not make the effort to provide a high level of care to normalize the airflow signal and thereby decrease the trips to the bathroom, risks increase for all these bad outcomes.
The above paragraph could be repeated for depressed patients who have tried multiple psychotropic medications for depression and are now labeled treatment resistant depressed patients. Not a small proportion of these patients also may suffer suicidal ideation and behaviors, and although the vast majority never commit suicide, the burdens they suffer from and the extensive healthcare services they require are clearly problematic to friends, family and healthcare providers. Research is somewhat prevalent on OSA/UARS and depression and rarely (but not non-existent) on suicidality and OSA/UARS. When psychiatrists and therapists fail to refer their patients to sleep centers, and worse when these patients are referred but then the sleep professionals refuse to evaluate for sleep-disordered breathing, the misery and suffering continues and unequivocally leads to greater morbidity and potentially mortality. Such patients never even have a shot at advanced PAP devices, because they’re often persuaded that CPAP would prove intolerable.
If you look closely at many fields of medicine where sleep disorders often surface in patients otherwise not viewed as sleep patients and we combine this problem with the high level of mediocre care among many sleep centers that solely fixate on CPAP, it is clear we are under-serving our patients. The wake up call needed here is the dire necessity to bring back patients into the sleep lab in order to receive advanced testing services, just as would be the case for virtually any cardiac patient.
With such an array of opportunities to use NDS therapy and other conservative treatment approaches, one of the most important research areas for study would address how non-sleep, medical professionals recommend these steps to their patients. Regardless of how things shake out in sleep centers, more health professionals and especially primary care physicians, psychiatrists, and psychologists (not to mention assorted mental health therapists) are going to be asking virtually all their patients, “How are you sleeping?”
Primary care physicians are probably the most pivotal group to study, because they experience directly or indirectly so much of the frustrations patients report in attempting PAP therapy. The complaints may consist of the specific difficulties in trying to use or adapt to PAP as well as complaints about dealing with sleep center or DME personnel, not to mention the ever present struggles with insurers that so often plague PAP patients.
Imagine a study that examined NDS therapy in the context of a very large primary care practice facility, the type that houses ten or twenty or more internists and family medicine physicians. These large groups are increasingly common due to mergers among many medical businesses as well as the tendencies for large hospitals to expand services to grow even larger.
In this main arena of healthcare, as awareness increases regarding the vast number of sleep complaints among their caseloads, eventually an executive or medical director of such a facility would recognize the epidemic in their midst comprising presumptive cases of sleep-disordered breathing, despite so many patients visiting their facility for just about everything else but sleep issues. With a very succinct questionnaire of ten items or less, a triage system could easily identify patients with presumptive SDB. How then would these physicians proceed to engage their SDB patients in orderly fashion to take steps towards diagnosis and treatment? Would they all be referred to a sleep center? If so, how long would it take for the patient to be tested? What kind of testing would be available? Who would be running the DME program?
If the answers don’t immediately come to mind, consider what is happening right now in primary care. When a patient mentions a sleep complaint, the more immediate evaluation might be towards insomnia and the need for sleeping pills, over the counter or prescription. However, there are newer trends indicating physicians are increasing their frequency of questions about snoring, witnessed apneas or other problems with sleep quality. If a primary care patient reports problems with sleepiness or fatigue or medical co-morbidities, like high blood pressure or arrhythmias, there may be even greater attention given to underlying sleep issues as more and more physicians focus in on these connections.
The bottom line is that sleep disorders will eventually fall into the same paradigm as seen with other chronic conditions. Originally, psychiatrists treated depression, or endocrinologists treated diabetes. Over time, and especially as it related to medical management (i.e. medications), more primary care physicians (for better or worse) acquired the training, experience or habit of treating patients with depression or diabetes and no longer relied on the specialists. They learned enough information to prescribe medications, and the best among them kept current on trends and evidence in the field to guide their adjustments to these medications.
This same pattern for sleep disorders is going to evolve in the primary care setting sooner than later, because of the overwhelming number of OSA/UARS cases to be treated coupled with the inadequate number and distribution of sleep specialists. In other words, it is this area of clinical care that will soon be the most ripe for research investigation of conservative treatment steps, because all these patients will not make it to a sleep center or certainly not in a timely manner.
Bear in mind, however, that entrenched thinking about NDS therapy in many areas of medicine in general, and even in sleep medicine in particular, either ignores the potential value of this treatment strategy or denies its efficacy. This constrained view actually creates a much greater potential for game-changing research, because an investigation among primary care patients successfully using NDS therapy could bring us to a very desirable tipping point. And, what’s even more interesting about this potential change in thinking is it would lead primary care physicians and other primary care providers to increase their awareness about sleep issues to the point of raising more questions and making more referrals. To be clear, this process is not one of “if you build it, they will come.” Rather, knowledge that something works or has a reasonable degree of probability for working will inspire providers to gain more awareness of sleep issues, because they would possess a simple recommendation to offer to their patients.
As an aside, I recently conducted a two-day workshop for a group of mental health providers in Chicago, who invited me to teach them how to manage sleep disorders in their practices. As I have mentioned previously, mental health providers have a very different slant on sleep disorders than most other areas of healthcare, because virtually every day they are seeing a lot of patients with sleep complaints, because sleep symptoms are a major component of mental illness. As often happens near the end of the workshop, we must discuss how the mental health practice must interact with local sleep centers, and typically the discussion leads to concerns about barriers arising. The largest barriers are that so many sleep centers do not recognize the high prevalence of OSA/UARS in mental health patients and instead write off their sleep complaints to psychiatric disorders. Indeed, even if a patient from a mental health facility is sent for sleep testing, it is not uncommon for the diagnosis to come back with the following words: “mild sleep apnea and the patient should avoid sleeping on her back.” In other words, they often miss the UARS component of the condition, or they simply believe that since the OSA diagnosis is merely mild, then the patient’s mental problems must be the real culprit needing the most attention.
At this point in my workshops, I spend a great deal of time explaining the rationale for conservative sleep breathing treatment strategies, all focused around nasal hygiene. In my discussion of NDS, I explain how to use the nasal strips, how to place them correctly on the nose, and how to remove them to avoid any skin irritation. In this discussion, you can figuratively see the light bulbs forming above each attendee’s head, because they realize they’ve just been handed a tool to use directly in their practice without having to wait for everything to be managed by a sleep center. I will return to the mental health arena as another area for research, but I want to pick up on the rest of the topic of primary care.
A related example in primary care is how physicians currently view the role of melatonin. The growth of melatonin did not start with the medical world, so to speak. Instead, it was pioneered by the alternative medicine community, where the role of vitamins, mineral, supplements and other so-called natural remedies are promoted with great vigor. Melatonin was advertised all over the map as a natural supplement for insomnia, and because melatonin is a known hormone naturally produced in the body at night during the sleep period, it seemed logical people would buy into the idea of it working as a sleep aid. Yet, the research in terms of well conducted studies only showed a likely need for melatonin among elderly people with melatonin deficiencies or for those with jet lag issues. This limited evidence did not impede the suppliers from advancing their marketing into the global population of those suffering from either insomnia or poor sleep quality, a quite sizeable number of people.
As a result of this push from the manufacturers of melatonin, physicians began to see and learn about the supplement because their patients were self-selecting it to treat insomnia or poor sleep quality. This phase of development went on for years until finally enough doctors heard such positive results from their patients; the physicians themselves started recommending melatonin. Next up, more research or more manufacturing innovations have led to increasingly sophisticated melatonin concoctions. And, in just the past year, a new extended release melatonin has come on the market, following a very well-conducted, placebo controlled randomized controlled trial to prove its benefits. This product is likely to spawn more melatonin supplement research, more products and more growth in the sale of melatonin products.
The above example of patient-driven use of a product is already what we see in the marketplace for NDS therapy. The promotion of nasal strips has not been as aggressive as that conducted for melatonin, but the pathways are still similar. Patients are driving the sales of NDS, much more so than doctors are recommending NDS, even though there is sufficient evidence for physicians to already be considering such recommendations.
For these reasons, locating one large primary care practice and working with that group to teach them about conservative treatment steps, including nasal hygiene in general and nasal strips in particular would be the ideal scenario to research from the standpoint of wanting to see more patients start their OSA/UARS treatment sooner than later. By the way, virtually everything discussed so far and going forward also applies to the DME environment, because so many sleep centers do not rigorously work on nasal hygiene programs for their patients. Thus, conducting research at a DME would permit application of NDS therapy on one group of new PAP users, which would be compared to another group not offered NDS therapy.
A research project of this type ultimately requires certain premises to bring into play all the necessary variables to yield comprehensive results. The most difficult premise to deal with is whether or not a patient suffers from sleep-disordered breathing even if the condition turns out to be mild. (Of course, the premise is easily solved in a DME environment where patients have already been diagnosed and prescribed PAP). In seeking to create a context where primary care physicians would accept and eventually embrace the outcome of the study, patients would require the diagnosis of a sleep breathing disorder on HST, which would be the most expedient way to recruit the right patients. However, the HST must be of the type such as the WatchPAT to account for UARS.
The next premise would to identify the right outcomes for measurement pre and post NDS therapy. From past research, we already know NDS therapy will improve quality of sleep and quality of life measures as well as decreasing insomnia severity and impairment related to fatigue and sleepiness. Four scientifically validated measuring tools were used to determine the efficacy of NDS therapy in our 2004 original randomized controlled trial. And, by the way, these changes were not on a small scale. All improvements met statistical significance criteria for medium to large effects. As the best example, insomnia severity in the NDS group from a starting point designated as moderate severity ended up decreasing to below the actual cut-off for clinically relevant insomnia, that is, scores dropped from 15 to 10 on average, which represents a huge change for the better in the insomnia condition. Even among secondary variables, such as nocturia, morning headaches, and dry mouth upon awakenings, the findings showed consistently more benefit in the NDS therapy group compared to controls, although for these variables the sample appeared too small to achieve statistical significance. One of the most remarkable aspects of the research was how the patients treated with NDS therapy consistently reported across the board subjective improvements in breathing symptoms, in various sleep quality symptoms, and in various insomnia components.
Thus, there would be a host of variables from which to choose in a research investigation to prove that patients were gaining better sleep and related outcomes with the sole use of NDS therapy for their recently diagnosed OSA/UARS. To make the research as feasible and expedient as possible, we would expect to use the least complicated measures and the fewest in number.
Another premise is whether or not to design a research protocol with exclusions. For example, would you want someone with chronic pain using opiate medications to enroll in the study or would you be worried both the pain and the opiates might make it difficult for the patient to discern any changes in their sleep? What about someone on multiple psychotropic medications for multiple psychiatric conditions? Many of these drugs numb patients during waking hours and also affect sleep in various ways. Would these individuals prove to be reliable research participants? Or, what about a patient who suffered a propensity for skin irritations, for example easily sunburned or very dry skin? Would these people be able to tolerate the adhesive of a nasal strip? Most research looks to clarify the most important or clinically relevant exclusions, but in general the more exclusions yields final results that are less meaningful or generalizable to the community at large.
A final premise to consider is the duration of the study. The longer the protocol runs, the more meaningful the data. Our RCT for nasal strips only ran 4 weeks, yet the results were fantastic after just this short period. We even recognized that lots of patients had done well after two weeks of use. Still, after the controlled study was completed, we continued to monitor the majority of patients who agreed to wear the nasal strips for another 8 weeks, and in the new extended window several patients who had reported no prior improvements in that first month now reported clear-cut benefits with longer use. Anecdotally, there were a small number of patients who still could not detect any differences from using NDS until they stopped using the strips for a few days or a week. Then, it crystallized in their minds how much better sleep was as soon as they began wearing NDS again or the reverse, that is, they realized how bad sleep was without the nasal strips.
When such studies or the many variations of protocols are completed, we would expect to come close to overcoming the tipping point for the awareness of the high prevalence of sleep breathing symptoms and disorders in primary care clinics. Moreover, we would further expect to see a notable change in perspective where providers think more urgently about starting treatment of these problems at the primary care level instead of waiting to treat OSA/UARS at the sleep center level.
As described above, mental health is also a large arena in which to conduct NDS treatment research. Arguably, mental health is the largest domain to consider for advancing the use of conservative treatment steps for OSA/UARS, because the epidemic of sleep-disordered breathing in this milieu is astronomical, even larger than what’s seen in primary care. However, the problem going forward is the huge gap of awareness between what mental health patients are complaining about and how their doctors and therapists are interpreting these symptoms. As the best example, we’ve done numerous studies on the sleep in PTSD patients for whom I must point out the PTSD diagnosis almost always includes reports of two sleep disorders: nightmares and insomnia. Indeed, our earliest work in research was to treat the nightmares of chronic PTSD patients, where we applied a cognitive-imagery technique known as Imagery Rehearsal Therapy with great success. In the course of that study that lasted more than six years from inception to publication in the scientific literature, we became increasingly curious about what appeared to be the much greater complexity to the sleep disorders in these research participants, all of whom were young to middle-aged female sexual assault survivors.
The findings that repeatedly emerged in other studies and which were subsequently published in 16 different peer-reviewed articles in psychology, psychiatry, sleep, or respiratory journals unequivocally demonstrated a high frequency of OSA/UARS in trauma survivors. As you might imagine though the idea of a trauma survivor attempting to use a PAP mask is often a nonstarter. And, although we have had considerable success in using advanced PAP devices in this population, this group of patients would on the whole be far more receptive to conservative treatment steps.
Another gap arising in mental health research is to persuade the mental health providers that the sleep complaints they are hearing about from their patients are in fact masking their underlying sleep breathing conditions, that is, if someone is talking about nightmares or insomnia, why would you suspect OSA/UARS? And, to reiterate, if the mental health provider enlists the aid of a sleep center or sleep specialist, they will not infrequently be ridiculed or simply dismissed for sending a “psych” patient for an evaluation of a medical disorder.
With this backdrop, conservative treatment steps involving nasal hygiene in general and NDS therapy in particular is an ideal match for mental health system patients. One of the best aspects of a research protocol in this arena involves the high frequency of regular patient visits into the system. Many mental health patients visit providers weekly or bimonthly or monthly, which means a protocol could easily be introduced into the regular workings of their systems. Not only would follow-up be easier, but treatment adherence would probably exceed 90% due to the regular contact with a psychiatrist, psychologist or therapist. And, management of side-effects would be much easier, because patients would be reporting complaints in a timeframe where they would likely be seen again just a few days later.
Ultimately, conservative treatment steps for mental health patients may prove to be the only way forward, given how much resistance already exists among sleep professionals to seriously consider their sleep complaints coupled with some of the trends described earlier in which contraction of sleep center services appears to be on the horizon. NDS therapy then could easily function as a bridge treatment between primary providers and sleep centers, albeit many of these patients will continue to show reluctance for more advanced treatments, such as PAP devices or dental devices, due to high levels of claustrophobia in this population.
Finally, a whole other area of research involves various types of limited or non-treatment seeking individuals. A very common type would be the individuals with sleep complaints who don’t talk to their doctors but do visit drugstores for relief. Another subgroup here would be those with sleep complaints who talk with no one, and they do not seek relief at drugstores, even when their problems are as apparent as chronic nasal congestion. Yet, another group has no sleep complaints or any nasal issues, but they are the type seeking an “edge.” They may want to run faster or improve their endurance. Or, they want to walk faster or swim easier. Thus, they might start by using a nasal strip for daytime performance, and through the passage of time, they may wonder whether NDS would have some impact on their sleep. These groups tend to fall outside the domains of traditional medical or healthcare services, but they are interesting in that they reflect an area of patient-driven forces that promote the use of OTC medications or devices and thus play a major role in how products emerge and expand within the marketplace.
Sourced From Classic Sleep Care- In 2015, we last discussed nasal strips (NDS) in depth to point out their wide applicability. With increasing experience, I would like to update a few aspects of this conservative yet effective treatment strategy, because I see certain trends indicating a larger growth potential than previously forecast.
As briefly mentioned in a recent post, a close relative of mine used a nasal strip one night and was stunned by the dramatic improvement in sleep quality noted on his Fit-Bit. He was also intrigued by the notably enhanced sleep quality he experienced that night and was unequivocal about sleep being more refreshing and daytime energy levels being higher. However, this individual was not a treatment-seeking sleep disorder patient. Rather, his experimentation with NDS derived from a chance conversation at a family outing. Eventually, despite these apparent gains, the individual experienced no concomitant motivation to maintain regular use of NDS, though it is used occasionally.
A second related case involves an individual I met on a recent trip, and with more time for a more involved conversation, we discussed three chronic health problems including hypertension, nocturia, and cardiac valve disease. This scenario was diametrically opposite than that of my relative, because this gentleman has been under the care of multiple doctors, yet none of them have mentioned the imperative to undergo overnight sleep testing, whether by home sleep testing (HST) or polysomnography (PSG), despite the presence of these three conditions, well-known for their inter-relationships with OSA. When we discussed these connections, he was eager to learn more for no other reason than the age old wisdom that “suffering is the greatest motivator” to seek solutions to health symptoms. Though he anticipated having difficulty with using a CPAP device, he was intrigued by the notion of NDS actually providing benefit and literally left our meeting to head directly to a local pharmacy. The next morning he too marveled at the immediate improvement in nasal breathing. Of additional clinical import, his wife declared he had not slept so peacefully and soundly in years. In his case, NDS will be used for as long as it takes to complete formal sleep testing and might be used thereafter in conjunction with PAP therapy.
These two cases manifest the polar extremes of NDS use. In the first case, we have a non-treatment seeking individual who happens to gain new knowledge about nasal strips and elects to try it a few times. Despite marked improvement, there is no motivation to keep using it. In the second case, serious medical disorders and symptoms are in play, and the individual is eager to attempt any treatment immediately to gain even the slightest improvement.
From a marketing standpoint, it should be apparent that the latter case describes people who could walk into a local drugstore to explore various nasal strips for sale. In the former case, the individual would walk right past the nasal strip section, arguably because he or she would have never heard of the product or its applications.
Based on trends I am observing in the field of sleep medicine, I believe this marketing issue could change in ways that will more readily see patients incorporating NDS into their sleep care, because of two paradoxical influences. One, we are witnessing increasing awareness of the OSA/UARS epidemic in our country and elsewhere, but two, this awareness is now coupled with a corresponding contraction of sorts in sleep medicine services. If the contraction in sleep medicine services worsens, it will perforce lead to more and more individuals searching for conservative treatment options such as NDS.
The first component of this equation—increasing awareness of OSA/UARS epidemic—is a no-brainer, because so many different fields of medicine are now referring patients to sleep clinics and labs. Some of the more obvious growth is in the field of cardiology and cardiovascular disease, where cardiologists are now embracing the viewpoint that nearly all their atrial fibrillation cases as well as congestive heart failure patients must undergo sleep testing, due to the aggravating effects of OSA. Some cardiologists refer patients for additional cardiac arrhythmias or for coronary artery disease. And, despite the fact there is increasing scientific evidence for referring cardiac cases, this new influx of heart patients into the sleep medicine environment is actually driven much more by doctors witnessing changes in other patients who after having used PAP therapy witnessed an elimination in symptoms or a decreased severity of symptoms, specifically eradication of arrhythmias or easier management of congestive heart failure with PAP therapy.
In psychiatry, I am literally reviewing a paper this week for a leading scientific journal on the topic of whether or not treatment resistant depression should mandate the use of sleep testing to determine if an OSA diagnosis might be the culprit for the lack of effectiveness of the antidepressants. More research is coming out in mental health on the connections between OSA and PTSD, such that you now see this co-morbidity mentioned even in what I call the same-stream media, that is, the place where once an idea takes hold it gets repeated as “news” virtually everywhere from newspaper, magazines, blogs and so on, which eventually turns it into the new conventional wisdom. Sometimes, this process is quite valuable to society, while more frequently than recognized the process turns elevates certain myths into entrenched dogma (i.e. conventional wisdom), such as described below regarding the so-called optimal number of hours of sleep conundrum.
The list of interconnections and enhanced outcomes goes on in other realms as well, such that now we see that many current OSA patients and their assorted doctors are spreading the word that sleep breathing disorders are a big deal. I am not declaring this trend as the ultimate tipping point, because there is still quite a ways to go, but I am persuaded the recent changes reflect another very large step forward in this inevitable process where eventually nearly all relevant patients will be referred for sleep medicine services by their primary care physicians or by the patients themselves.
The matter of contraction of sleep services, on the other hand, is more complicated and not so easily discernible. The main factors involved are no different than what has been described previously in many places as well as on this blog site:
- Sleep testing services are allegedly expensive
- Home sleep testing should supplant in-lab sleep testing
- PAP has poor rates of adherence
- Alternative treatments to PAP must be developed.
- The shortage of sleep medicine physicians may never be resolved
- The sheer number of eventually diagnosed cases of OSA/UARS demands other pathways to treat the condition.
An entire blog post could be written about each of these factors. Here, we will attempt to integrate aspects of these issues to form a cohesive argument to explain how the contraction of sleep medicine services actually favors the advancement of conservative treatment options. In going through this list keep in mind how each step creates more limitations on patient care and thus leads to more patient frustrations, all which leads to individuals searching for add-on treatments to solve problems.
Whether or not sleep lab testing (PSG) is expensive and whether HST can supplant PSG are both essentially moot, because the “handwriting is on the wall.” In other words, the perception that sleep studies are expensive and that only HST can save the day is now taking root in medical circles and will soon become deeply entrenched as the new conventional wisdom among insurers as well as government regulators and primary care physicians. It does not matter how much lower the quality of care falls via HST, as it most assuredly will be in the short-term, because the verdict is already in that the HST/APAP model of care is not only comparable to the sleep lab approach, but also, adherence rates with HST/APAP are just as good as the lab approach. And, because adherence (de facto hours of sleep per night), not quality of sleep, is the benchmark through which sleep medicine services are judged for OSA/UARS therapies, quality of care must decline as it always will when sleep professionals focus too much on how many hours of sleep someone is gaining instead of focusing on the quality of the individual’s sleep.
Once society succumbs to the fallacy that hours of sleep are more important than sleep quality (a fallacy deeply entrenched in societal viewpoints about sleep), then it becomes apparent that no matter how you teach someone to gain adherence status (i.e. 4 hours per night for 5 nights/week), all subsequent emphasis will disregard a patient’s persisting sleep complaints, because the ultimate goal has been achieved—the so-called necessary number of hours of sleep. If you do not believe this statement, consider the following: there are sleep physicians and insurers all across the USA and elsewhere who literally believe their jobs are done once their patients become adherent. As a reminder, you know how often I talk about the connection between sleep apnea and nocturia and how we preach that at least 50% of PAP users should eliminate all trips to the bathroom. Moreover, we profess that this percentage is most likely an underestimation of the true potential to eradicate nocturia with PAP therapy. Nearly all evidence points to such outcomes, yet most insurers and even lots of sleep professionals remain convinced to simply ignore or lose sight of the nocturia connection, despite this highly problematic symptom continuing to affect so many successfully adherent PAP cases.
Adherence or the number of hours turn the sleep medical system upside down and degrade the quality of care in a large majority of cases. Eventually, these patients are going to become frustrated if not angry for the inadequate if not mediocre care they are receiving. Many may take a long time to sort out these deficiencies, because it is so hard for people to determine what a higher quality of sleep represents over either the short or the long-term. But, sooner or later, they will hear about the failure of their sleep professionals to direct them in new or different ways to solve problems previously believed to be unsolvable, like nocturia. I have met thousands of patients treated by board-certified sleep doctors, who never informed these patients their nocturia might disappear once they attained an optimal response to PAP. Instead, they simply repeated the empty mantra: 4 hours of sleep for 5 nights per week. In the meantime, their patients suffer the consequences of inadequately treated sleep-disordered breathing.
In due course, people learn enough from other people or other information resources that will lift the veil on the poor services they are receiving. And as these insights are experienced by increasing numbers of patients with poorly treated OSA/UARS, they will demand alternative treatments. One of the up and coming approaches is the Inspire technology that implants a neurstimulation device into the body in ways similar to a pacemaker and which creates a pacemaker-like system that stimulates the nerves to the base of the tongue. This device causes the tongue to retain greater rigidity while sleeping and thus decreases the apnea-hypopnea index. There is an even a titration component to the Inspire system, theoretically making it plausible to incrementally increase the capacity of the device to decrease UARS breathing events, aka flow limitations or RERAs (respiratory effort-related arousals).
Furthermore, all during the advent of the field of sleep medicine, many patients underwent surgical procedures to treat the condition, and surgical options are also going to see more precision and efficacy in the coming years. The same is true with OAT, where increasingly sophisticated dental devices will improve the quality of sleep.
If you summarize the above information in terms of services, it sounds like there is a broadening of options for patients. However, few of these options except PAP actually lead to superior or near optimal to optimal results. Instead, these options all provide some degree of efficacy, but most cannot compete or attain a state of equivalence case by case with PAP. Thus, the contraction we are describing here refers specifically to sleep center services, involving the use of the sleep laboratory environment to initiate and optimize the application of the gold standard therapeutic option of PAP therapy. These services are on the decline, because sleep centers are under attack for using in-lab tests that are allegedly too costly, because HST can replace PSG allegedly without a decline in care, and because patients allegedly don’t use PAP much anyway so why bother with all the expensive care when it goes to waste. To be clear, there are many sleep centers still functioning at high operational lab levels. But, as these anti-lab viewpoints become entrenched, more and more doctors especially PCPs who often hear the horror stories of patients suffering through the adaptation problems of PAP will start referring more of their patients to surgeons and dentists or anyone else who can offer alternate remedies.
In some ways, this emerging phase in the field of sleep medicine could lead to healthy competition, wherein sleep centers and DMEs learn to work more closely together to provide faster and more efficient adaptation approaches, so that patients enjoy the benefits a lot sooner while suffering thru the PAP hassle factors a lot less. Doing so would likely shift patient loads back toward PAP, but it remains to be seen how well sleep centers and DMEs can coordinate efforts, and it remains to be seen whether either or both institutions will raise the banner to focus on better sleep quality, which 99% of the time is the only way to point a patient toward optimal results.
More probably, over time, as sleep services decline in the main clinical fields of sleep medicine, we would expect services to increase in fields of surgery or dentistry, leading to new standards on what constitutes gold standard treatment. As pointed out in a previous post, for a long time surgeons have been using the decidedly non-scientific and non-clinical metric of “50% decrease in sleep breathing events” as a marker of success. It is difficult to imagine how anyone could imagine declaring a procedure that drops the AHI from 41 to 20 as anything resembling success and certainly has no relationship to the clinical construct of “optimal” treatment. Yet, years from now, I would not be surprised that the very idea of PAP might fall into such disrepute, these older and less valid benchmarks will somehow be declared the new gold standard of OSA/UARS treatment. Regrettably, that’s how government regulators and insurers want the public to view these things, so they can continue their push to see more contraction in sleep medicine services.
Ultimately, the convergence of all these changes in these fields will result in patients clamoring for better care, as one example through add-ons to their current, less optimal care with surgery, dental devices and of course mediocre responses to PAP.
The most recognizable case in point was the addition of REMZzzs mask liners and Pad-a-Cheek mask liner systems that dealt directly with the discomfort and pain caused by many masks. NDS therapy appears to represent greater potential, because it can serve as both an add-on as well as a stand-alone (at least temporarily) system for dissatisfied PAP consumers, OAT users or post-surgical patients still in search of more benefits
Many of these patients will be driven to explore and experiment with add-ons as they realize the sub-optimal results they are receiving are not the optimal results they’ve been told they are receiving. In politics as elsewhere, this process is call “dumbing down.” Its purpose is to literally have people believe what they are getting is at a level of quality much higher than what they are actually receiving. One of the most glaring examples of this phenomenon is when a particular insurance company incessantly touts its high quality of care in all its promotional efforts while on a local level you may find thousands of unhappy consumers who know first-hand the insurer’s primary focus is not quality of care. Only when a cascade preference (the phenomenon where a whole bunch of people realize that what they know privately is actually the same piece of information held by thousands of other people) erupts would you then suddenly witness that the insurer loses a ton of business at the local marketplace.
We are talking now about a cascade preference in the opposite direction when patients finally realize they need and should be receiving more gains from their treatment. At the most expensive level, this change will be directly related to advanced PAP devices, whereby ABPAP and ASV will be universally accepted as head and shoulders above CPAP devices.
At the conservative level, the use of NDS and related nasal patency treatments, mostly commonly treatments for allergic rhinitis, nonallergic rhinitis, and rhinosinusitis, will probably emerge much faster in this developmental phase, not only because of the pronounced cost-effectiveness, but the greater ease of marketability. As you may recall from our nasal breathing video series on www.sleeptreatment.com , we promote a zero tolerance policy regarding nasal congestion or nasal patency issues. We declare there is no such thing as an optimal response to PAP therapy unless a patient can attain a state of perfect nasal patency.
In our research paper published in Sleep & Breathing, we discussed how the overwhelming proportion of patients with sleep disorders of any type, not just sleep breathing conditions, suffer from either allergic or nonallergic rhinitides or both. Thus, just by sheer numbers, a cascade preference involving the use of NDS and related nasal patency treatments seems like a very promising area of conservative clinical treatment options for innumerable patients.
Finally, in our publication more than one decade ago, we conducted the first and only randomized controlled trial of NDS, which clearly demonstrated that insomniacs with suspected mild OSA or UARS reported notable decreases in symptoms just after one month of NDS use. Here, then, is a perfect example of NDS applied to patients who see themselves as other than classic OSA patients, because none of the sample included people who believed sleep breathing had caused their insomnia.
In the next post, I would like to delve into some research ideas on how to promote the use of this conservative approach to sleep disorders treatments. Although creating new conventional wisdom and developing astute marketing strategies often prove more important in the short-term to advance these therapeutic options, long-term we find that innovative research complements these commercial interests.
Sourced from Classic Sleep Care- We last discussed chinstraps and the difficulties many patients may have in their attempts to consistently use them. Eventually, some of these patients must gain access to the sleep lab as they are unable to accurately manipulate the chinstrap into their mask system. As noted, even something as straightforward as wearing the chinstrap inside the mask (nontraditional) versus outside the mask frame (traditional fitting) may still require a trip to the sleep lab, if we can persuade certain insurance companies to grant the authorization for testing.
In the examples that follow, you may or may not be surprised to learn how finicky some insurers operate to block the process entirely or complicate things so much as to erase any further patient motivation to move forward. On the other hand, we continue to be impressed with Medicare’s stance that permits the sleep physician to make the final call on which patient may need a sleep study. While many complain about Medicare’s rigid and arbitrary approach to compliance definitions as well as its lack of coverage for UARS, it is crystal clear Medicare has chronic budgetary problems and simply cannot afford to pay for devices that patients do not use. There is no excuse for Medicare not covering UARS, but that’s another story. To its credit, though, Medicare is willing to go every last mile to help OSA patients become compliant by creating very easy access to the sleep lab.
In these examples, you will notice how the scenarios might play out based on an insurer who requires an authorization to return to the lab versus those requiring no authorizations.
One of the most obvious objective findings mandating a return to the sleep lab is the new or persistent finding of central sleep apnea events showing up on a patient’s data download. We’ve discussed the advantages previously for the use of ASV for central apneas, and we’ve mentioned our REPAP study where many patients failing CPAP eventually demonstrated sufficient central apneas to qualify for complex sleep apnea (the technical diagnosis for what is otherwise called “treatment-emergent CSA,” meaning the treatment of PAP triggered the central apnea problem). If you were to see this problem on a Medicare patient’s download at any point in follow-up, it would be reasonable to consider a return trip to the sleep lab to determine to what extent these central apneas are interfering with the patient’s response. To be clear, a patient on CPAP, APAP, BPAP or ABPAP manifesting central apneas, but who also reports fantastic improvements in outcomes, no leak issues or mouth breathing, and no previous findings or suggestions of leg jerks, would have no obvious rationale for returning to the sleep lab. Such patients in fact do not want to return to the lab; and, no persuasion is attempted to pursue such a step, because of the excellent response.
Notwithstanding our prior discussions of the ceiling effect where patients might be overestimating how well they are doing with PAP, the finding of central apneas do not always indicate a patient is suffering a poor PAP response. Indeed, the consensus of the conventional wisdom in sleep medicine (which I dispute) is that central apneas may appear and then dissipate in many first time PAP users. We dispute this consensus because of the thousands of CPAP patients we have retested in the sleep lab who were presenting with mixed results and yet still demonstrated central apneas many months or years after initiating treatment. In other words, their central apneas did not disappear and were likely still preventing them from achieving an optimal response to PAP. When their outcomes, most commonly reports of persisting awakenings, sleepiness, fatigue and nocturia manifested in ways where treatment gains were observed to be minimal, we know the patient is likely to fare better by returning to the sleep lab and exploring the potential for the diagnosis of complex sleep apnea.
Now, here’s where things get really interesting, almost amusing, and certainly frustrating for those patients who are signed up with one of the largest insurers in the country. If one of their patients shows central apneas on the download, the insurer then initially rejects the authorization if the patient has been using their CPAP or APAP devices with the expiratory pressure relief (EPR) setting in place.
If you don’t recall, EPR functions like a mini-bilevel device, that is, the person inhales at one pressure, but when the individual goes to exhale, then the EPR setting drops the pressure slightly in a range of approximately 1 to 2 cms. Although this change might vary based on the manufacturer’s design of the device, you can think of the settings as if it were a bilevel device with pressures of 10/9 or 10/8 or maybe 10/7. Now stop for a moment and ask why anyone would be using EPR? The answer is easy if you have kept up with these posts, because we frequently talk about expiratory pressure intolerance or EPI. In our experience, EPI is the real culprit involved in so many patients rejecting or failing CPAP. While central apneas often appear in these patients, the EPI is really the iceberg and the CSA is really the tip of the iceberg.
The problem of EPI is so vast, it actually explains why various manufacturers invented EPR technology. Moreover, these same manufacturers recognize that EPI is a more prevalent problem compared to CSA. Still, with some degree of irony, it can be noted that in years past bilevel was actually a treatment for CSA, and yet there has also been some data suggesting bilevel might increase ventilation, blowing off CO2, and eventually triggering central apneas. You can see how much confusion resides in discussing bilevel, because we just stated that it could treat CSA while then stating some believe it causes CSA. Go figure.
Meanwhile, back on the EPR device, the insurer in question looks at data downloads, but if the EPR setting is turned on, then the patient’s symptoms are declared null and void, based on the assumption the mini-bilevel might have caused the problem of CSA. So, what does the insurer demand? The patient must turn off the EPR component of the CPAP or APAP device and then return 2 weeks later to determine whether central apneas as originally seen on the first download are still present. Now, I am not suggesting this theory is completely unfounded, but I can report I have never seen a single case where the central apneas disappeared after someone turned off the EPR component. More tellingly, virtually every patient who goes through these steps reports the worsening of EPI as soon as the EPR is turned off and the worsening of sleep quality and daytime symptoms without the use of this advanced mini-bilevel mechanism.
In my opinion, the insurer is clearly not acting rationally, because they are subjecting the patient to worse conditions that lead to worse sleep, which could in fact cause the patient to drop out of care altogether. Moreover, they have not updated their literature searches to recognize that bilevel is more likely to help CSA patients than to aggravate a CSA problem. Finally, a rational actor would do their homework and recognize how common central apneas are in patients failing CPAP and react proactively by wanting these patients to return to the sleep lab to see whether the problem can be fixed whether with ASV or perhaps some simpler method, as simple as fixing previously undiagnosed or untreated mouth breathing masquerading as central apneas.
No such depth of thought goes into this process with insurers. Instead, it’s all about ASV being expensive, therefore insurers approve seemingly reasonable steps to make sure no one gets ASV. In contrast, more patients who go on ASV are likely to be more regular users of PAP, which should yield better outcomes and ultimately decreased healthcare costs. If insurers acted in this manner, they would also build up their public relations images and win a great deal of loyalty among their consumers.
One of the most idiotic of insurer rationales is the not infrequent rebuttal to our appeals, delivered as the following verbatim, “the patient just needs to try harder.” We are no longer surprised to hear this refrain when we are going through an authorization process in a patient who is noncompliant, that is, is not attaining the metric of 4 hours for 5 nights per week per Medicare rules. As you probably know, many insurers use this metric for adherence, despite its arbitrariness. By the way, in this example, we are of course not discussing Medicare, because they do not require authorization. As their goal is to see the patient become adherent, they admirably have placed no restrictions on scheduling sleep studies in noncompliant patients. Indeed, they rule the patient must return to the sleep lab.
We are talking about an insurer who declares the only possible reason to explain a patient not adhering to PAP could only be the absence of motivation in the patient to do so. Here’s an example of how this story unfolds. The patient completes testing for the diagnosis and treatment of OSA and is prescribed a PAP device, usually CPAP; and, in this instance, the patient has tried using the device for about a year at some other sleep center in town. When we see this individual for a 2nd opinion, we review the case, looking for obvious problems that might be fixed before sending the patient back to the sleep lab. The most common issues arising would be related to mask fit, mask comfort, mask leak, mouth breathing, and difficulty adapting to pressurized air.
As you can imagine, we as well as the patient’s DME company can tweak all these components of PAP. The patient can be fit for a more comfortable mask and even briefly test it to see if leak seems better. This exercise by the way often proves useless, because it does not account for all the positions and movements a patient experiences during sleep. The same goes for any attempt at mouth breathing.
The new mask might appear to solve the problem when coupled with a chinstrap, but in our example, the patient goes home, tries all these new components, but then returns with the same lack of adherence. Other steps would be to add REMZzzs mask liners and to adjust the pressure up or down depending on the residual AHI and the degree of persistent flow limitation (flattening index on many downloads). Again, the patient returns with a lack of adherence.
So, any and all of these steps could be and were attempted in our example, but the patient complains they just can’t keep the mask on for more than 2 to 3 hours per night. He either removes it intentionally or notices it was ripped off at night during the sleep period. The patient, mind you, is very motivated to use PAP but now becomes increasingly frustrated that the milestones set by the insurance company just cannot be achieved.
It is at this point, we explain all these steps to the insurer and then after a first request for an authorization is sent in and rejected, there is a follow-up phone call with a medical director at the insurance company, a medical director who is rarely a sleep doctor. We have a short discussion of the events that have transpired, and then the medical director plays his trump card, “we assume the patient must not be that motivated to use PAP and is going to have to try harder to become adherent.” In a virtual Catch-22 moment, we explain the patient is trying very hard and has attempted a series of new steps that haven’t worked, so he needs to return to the sleep lab. But, the medical director again responds, “we need to see the patient trying harder to gain adherence, before we would consider authorizing a return to the sleep lab.”
I cannot begin to describe how irrational these responses are from the medical director of a major insurer in the USA. The idiotic part is that this medical professional is expressing a complete lack of knowledge on how patients adapt to pressurized air, which in our case example is not just very slowly or gradually, but more important, our patient is actually adapting quite poorly. And, the reason for much, maybe all these problems, is the use of the fixed pressurized air of CPAP. We even explain to the patient that there are other systems available such as bilevel that will enhance adaptability, but we cannot move forward with the new device due to insurance restrictions. Adding to the Catch-22, most insurers never allow for a switch to a different device unless the patient returns to the sleep lab to demonstrate a problem with CPAP. The problem of course is the insurer does not authorize the patient to return to the sleep lab, because “the patient isn’t trying hard enough” to become adherent.
In this example, I want to be clear that the insurer never provided an authorization for the patient to return to the sleep lab, and the patient eventually dropped out of care. From that point forward, we simply stopped working with new patients who use this major insurance company, because we informed the patient we would not be able to provide satisfactory care due to the insurance restrictions. Interestingly, previously established patients already prescribed and using an advanced PAP device such as ABPAP or ASV had less difficulty receiving authorizations to return to the lab, if they suffered from poor outcomes, perhaps because previously they had achieved adherence.
In effect, we are dealing here with the larger issue of adaptability, which I trust you understand as something more important than adherence, because adaptability drives adherence, especially among those with adaptation difficulties. Adaptability takes the form of both psychological adaptation and physiological adaptation and often the two are intertwined.
Psychological adaptation is governed by all the emotional reactions the individual may have regarding using PAP, including embarrassment, shame, guilt, and fear. These emotional responses can be so strong they actually prevent a patient from ever trying PAP therapy. Or, they flare up during the early attempts at use and trigger strong negative attitudes about PAP that result in noncompliance.
Physiological adaptation is governed by the physical sensations a person experiences with PAP and may be as simple as mask comfort issues, nuisance leak from a poorly fitting mask and difficulty in managing placement of headgear and tubing as it relates to adjustments of pillows or location by the bedside. The largest physiological issue is the sensations of pressurized air, which frequently converge with the psychological issues of fear and anxiety when the flow of air does not feel “right.”
The air “not feeling right” is arguably the greatest of all issues in a person’s struggle to use PAP, which is why we moved away from CPAP devices and towards BPAP and other advanced technologies. Fixed pressurized air as described above often triggers expiratory pressure intolerance, which patients frequently report, and if a sleep lab understands how to monitor EPI, they can also see it on the airflow curve in the sleep lab.
Most insurance companies caught up in the authorization game all but ignore this concept of physiological adaptation to pressurized air. And, by ignoring it, they get to make irrational statements about the patient needing to try harder. What the insurance company refuses to understand is that any adaptation problem must be resolved for the patient to be able to use PAP. And, while it is certainly understandable that emotional reactivity to PAP is more dramatic and thus more apparent to all concerned, it is in the vast majority of cases, more probable that the physiological sensation of fixed pressurized air or for that matter any form of pressurized air is the determining factor in whether or not someone adapts to PAP therapy.
So, what does it mean to physically adapt to pressurized air? And, why does the period of adaptation vary so much from individual to individual?
The capacity to use PAP varies so much because the device and all its accessories deliver new, unusual, unnatural, cumbersome or obtrusive sensations to the human organism. Worse, it is not a take it or leave it circumstance. These sensations are frequently experienced as new, unusual, unnatural, cumbersome or obtrusive to almost all individuals because PAP is attached to you. One slightly wide of the mark analogy would be like trying to adapt to a pair of uncomfortable shoes, because your podiatrist prescribed them for plantar fasciitis. Eventually, you would expect to get used to the shoes and even benefit from their use, but like PAP you can only adapt by their being attached to your body for a prolonged period of the 24-hour daily cycle.
For individuals who generally have no difficulties getting over the hump in trying out new things, the issue of CPAP adaptation is straightforward. They can put their noses to the grindstone and make it work, and eventually it does work. These patients constitute perhaps one-third of all those who attempt PAP.
However, in contrast, there are as many as two-thirds of patients who struggle in the early going, because PAP is not like adapting to say, switching to whole wheat bread to replace white bread. If your doctor informed you that the increased fiber in your diet from whole wheat is a necessity, you certainly might give it a trial period. But the process isn’t based on you having to eat whole wheat bread every day or three times a day or anything like having to wear a PAP device all night long. You might take months or longer to transition over to the potentially healthier whole grain bread, but each step of your adaptation is usually not a big deal.
With PAP, for highly sensitive people, every step of adaptation can be a big deal. EVERY.SINGLE.STEP. And, because each of these steps could be associated with pain or discomfort, the hassle factor in using PAP almost never seems to end for these individuals, which is a primary reason so many of them give up. And, what makes matters so much worse is that we are asking these vulnerable patients to manage nearly all the steps at home on their own without any sort of immediate back up plan.
Herein lies the great opportunity provided by the sleep lab. All these steps can be addressed in real-time, including both time awake and time asleep. The patient is a given a chance to show us he or she can put the mask on correctly, and then we can ask them to repeat these steps several times during the sleep study, if we discover improper mask placement is an ongoing problem. We can spot mask leak the moment it’s happening along with mouth breathing the moment it is happening. The sleep technologist enters the bedroom and helps the patient to understand that leak and mouth breathing are occurring and need to be addressed with chinstraps, new mask, mask liners, mouth taping or sometimes a simple change in sleep position. All these items had been addressed in the pre-interview, because leak and mouth breathing are such common reasons the patient has returned to the sleep lab.
If you are a PAP user and you have struggled at home trying to manipulate the mask to resolve mask leak, then you are fully aware of the immense frustration that emerges when night after night the problem keeps returning. Sometimes the leak wakes you up; other times the leak leads to a worse night of sleep even though you thought you slept all through the night; and still other times the leak varies so much you are clueless as to how to proceed in attempts to solve the problems.
Insurers clearly do not understand most, maybe all of the various factors we have been discussing in this series of posts. And, if you don’t really understand the nuances, subtleties, and sophisticated solutions provided by sleep technologists in the sleep lab (directed by their sleep physicians), then in my opinion, insurers will continue to act or react irrationally in trying to manage OSA/UARS patients.
Sourced from: Classic Sleep Care – Our over-riding premise in this post assumes that turning a patient into a regular user of PAP improves health benefits and saves healthcare dollars. Although the first half of the statement is a given, the second half remains controversial as we discussed in Part I. A fair number of research studies show cost-savings emerge by increasing PAP use, but no analysis has ever been conducted, to my knowledge, factoring in the costs of the number of trips to the sleep lab. Thus, to be fair, the remainder of this post must be weighed in balance against the speculative theory more trips to the sleep lab are not so costly as to eat up all the other gains to be realized, both to the patient and insurers.
We’ll start with masks because as conventional wisdom goes, most sleep professionals and probably most patients perceive mask fit, mask leak, and mask comfort as the ultimate deal-breakers. Our clinical experience indicates pressurized air is the larger problem, and in fact the type of mode delivering the pressurized air also influences these mask issues. Nevertheless, as so many people are wedded to the belief in prioritizing mask issues, we’ll follow the lead.
There are so many nuances to mask issues, but a universal problem afflicts nearly all patients and that is how they cope with the experience of mask problems. As each patient individually navigates attempts at new masks (types or styles), the most immediate deal breakers are discomfort or pain. Now, imagine you are a patient sitting at home about to go to bed. Maybe you have succeeded in putting the mask on your face, attaching the headgear, connecting the tubing and then turning on the pressure. At this critical juncture, if you feel any discomfort or pain stemming from the mask, no matter on your face, nose, or head, it is quite common to simply remove the maskf. Whether you are sleep-related institutions or professionals such as DME companies, insurers or sleep doctors, it seems apparent a fair number of healthcare personnel in this field just do not realize how rapidly mask problems lead to immediate rejection from which many patients may never recover.
Think about the above scenario. The patient has completed all the necessary testing to proceed to the point of filling a prescription for the PAP device. They may have even felt comfortable with the mask at a titration sleep study as well as during the initial setup period working with the respiratory therapist or sleep technologist. But, now in the comfort of one’s home, the patient must replicate the experiences, presumably positive ones, previously encountered in the lab or DME facility. And, what happens if the mask fitting, comfort and placement cannot be replicated? What if the mask causes unexpected discomfort and pain? What happens next?
Take the simplest and often most common problem of improper mask fitting. This issue might seem implausible to you if you don’t have first-hand experience as a patient or a sleep professional regarding the application of masks, but guess what: anywhere from one-third to one-half are fitted with the wrong size of mask the first time they are attempting PAP therapy. Not only are the sizes frequently incorrect, but the actual mask selection is just not going to work for a new patient. How could there be so much error arising in these circumstances. The answer is just as a simple. Every person has quirks to his or her facial structure as well as specific sites of sensitivities regarding comfort and pain. In other words, for more than 50% of first-time PAP users, it may be nearly impossible to find the best mask, fit it properly and confirm it is the correct size.
With so much variability in just these early encounters with masks, is it any wonder so many OSA/UARS patients drop out of care so quickly. Even if they have tried these masks in one night of testing in the sleep lab, the rates of misfits and mis-sizing are preposterously high. Now imagine the scenario of home sleeping testing (HST), where the patient is never trying out the mask in a way to match the lab experience. Instead, they are fitted in a short encounter at the DME, and then the patient must go home and try it all out. Again, for someone with the capacity to easily work his or her way through the trials and tribulations of getting the mask to properly, the series of adjustments are no big deal. However, for someone with greater facial sensitivities or a lower threshold to pain or discomfort, the process is next to impossible.
Enter the role of the sleep lab. In this environment the individual repeatedly receives hands-on adjustments for all manner of mask difficulties, but most importantly, they receive repeated adjustments throughout the night and as necessary they return to the sleep lab a week, a month or few months after initiating PAP therapy and again go through repeated mask adjustments. Most regrettably, there are many sleep professionals and technologists who just do accept these premises. They are somehow persuaded that patients are fitted properly with the best mask the first night of the study and these issues of pain and discomfort would resolve in due course. Again, while these perspective do manifest among that proportion of the population where PAP therapy adaptation is relatively easy, these viewpoints are way off base among the more vulnerable or sensitive patients where even the potential to find the right mask the first go-round is remote.
Making matters worse are the various insurance policies that do not permit swift transitions to replace the current mask with different ones before the usual 90-day window for such transactions. Thus, only among DMEs or sleep centers that create their own home-grown loaner programs will these vulnerable or sensitive patients have the opportunity to quickly gain a 2nd or 3rd chance instead of rapidly rejecting PAP due to a poor fitting mask.
Imagine the patient who is a horrible mouth breather, but who also suffers from claustrophobia. Do you give them nasal pillows (NP) to prevent claustrophobia or a full face mask (FFM) to cover mouth breathing? In an ideal world the patient might consider both, alternating them for a period of time. But in the real world of healthcare, the scenario plays out very differently. In those with clear-cut claustrophobic responses, they will never agree to early use of FFM, and some won’t even try on these masks. So, they use the nasal pillows in the sleep lab and agree to start with NP at home. Then, in short order, they report horrible dry mouth and want a solution. They might briefly try a chinstrap, but this step also induces claustrophobia. The bottom line is that the patient is probably ultimately going to need the FFM, but how long will they continue to reject it due to their psychological distress, and at what point would they quit PAP therapy?
Again, the answer is the sleep lab, where all these various combinations can be tried out in the safety and security of an attended study, where the patient is eager to experiment under the guidance and hands-on coaching from the sleep tech. These encounters occur frequently at our sleep lab, and the success rate is high, because the patient has proceeded with the understanding nothing would be forced upon him or her. Rather, through trial and error with the help of an expert, the patient believes it’s worth a shot to solve the mask problem. To be sure, the patient has already attempted to solve these problems at home and has typically failed outright or produced extremely inconsistent results. They want to use PAP, but in their minds, they cannot achieve success. This frustration motivates them to return to the lab, where it seems like the most rational way to approach the problem. However, under current insurance guidelines, the patient’s efforts to return to the sleep lab could be blocked for weeks or months or forever (as is the case with certain patient-unfriendly insurers) at which point they quit PAP therapy. Just one more night in the sleep lab might have turned things around 180 degrees.
And, we’ve just started with mask fitting and touched on mouth breathing. The additional problems of mask leak, pain, comfort and sizing all flare up in vulnerable and sensitive patients. And, no matter how dedicated and diligent a DME company might be in attempting to address these problems, it is not a small proportion of patients where daytime appointments will lead to less than adequate solutions, after which the patient will quit. And, remember, every step of the way, if the “cure is worse than the disease,” the patient will not experience our ultimate benchmark, “sleeping better.” And, anything that prevents improvement in sleep quality or worse, something that aggravates existing poor sleep quality, will almost invariably lead to diminished motivation in this cohort of patients and sooner than later rejection of the treatment and refusal to engage in the treatment.
Turning to mask pain, discomfort and sizing issues, it remains one of the weakest links throughout all efforts to manage OSA/UARS patients. And, why shouldn’t it be? Placing something foreign and unnatural on your face and expecting it to be worn there all night long seems far fetched. If you are old enough or experienced enough to know what masks were like in the 1980s, you would be shocked upon learning what was expected of the patient. The discomfort, pain, and irritation occurred with virtually every mask. When I first attempted PAP in 1993, I used a nasal mask and recall waking up all night long to adjust it so as to eliminate the pain on my upper lip and the gums of my teeth. Even with all the great advances in mask technology, which reflect huge strides of progress, it remains exquisitely difficult to size patients with the right mask, even sometimes the right size of nasal pillows for specific nostril openings.
We would all like for these issues to be like rocket science. Not even close. And, therefore, it requires the patients’ presence in the sleep lab for the implementation of very subtle adjustments to headgear and mask fit. A particular popular approach among my sleep techs is to teach patients how to spread laugh lines on their cheeks to smooth out the skin, doing one side at a time, and then placing the mask cushion. This technique may eliminate leak in patients suffering intractable leak problems. Another one is the proper use of REMZzzs mask liners, a widely under-utilized add-on that relieves pain and discomfort in a large segment of vulnerable and sensitive patients. Yet, it is very easy for these types of patients to exhibit difficulties in hand or eye coordination to properly fit the mask liners. Another area of common concern is the in-betweener, where the individual goes back and forth between medium and small or between medium and large sizes of any style of mask. Even in the sleep lab, this sizing issue may prove very difficult to resolve, yet it is in the sleep lab environment where the greatest chances of success are to be discovered.
To give you an idea of how difficult these tasks are in the absence of the sleep lab, I recently asked a few of my techs to predict which size of the Airfit Touch (F20) (FFM with the foam cushion) would be the right fit for me. Not only did I receive various suggestion for different sizes, but I also received specific comments about the likelihood of my being an in-betweener. My techs were only a little surprised when I informed them it was the large size that not only felt the most comfortable but also had completely eliminated the recent leak issues I’d been experiencing. Yet, the majority of techs presumed I would have had the greatest success with the medium size.
When I see second opinion patients, the most common problem is the failure of the previous sleep center consider a trial of advanced PAP, even just a bilevel trial, let alone ABPAP or ASV. And, we’ll talk later about this obsession with CPAP, but the second most common finding that diminished their chances to succeed were related types of obsessions with mask styles. Currently, it has become fashionable to declare that full face masks do not work well or that they cause side-effects or other problems in using PAP. Most of these sentiments fall into the categories of anecdotal evidence or weakly designed research studies, either of which lead sleep professionals to develop conventional and highly entrenched “wisdom.” I know of many sleep doctors and DME professionals who virtually refuse to let their patients even try out FFMs. We have worked with hundreds of second opinion patients who were stunned when we informed them of the existence of a mask that covered the nose and mouth. They expressed equal parts disappointment and anger directed at the prior sleep professionals who had not given them the opportunity to consider this option. Many of these patients found great relief moving from nasal pillows or nasal masks to the FFM. We have even published a paper on this phenomenon, describing in detail how over several months or longer patients transition from less invasive to more invasive masks based on the desire for better and more consistent results.
This rigidity to stick with one mask style is rife within the sleep community and flares up in various spots, including sleep technologists who have favorite masks, sleep doctors who insist they know what’s best for every patient, and DMEs often caught in the middle when they cannot convince the sleep center to let the patient try something new and different in mask types. Of course, these problems can occur in the reverse direction, wherein some DMEs hold fast to certain types of masks and brands due to cost factors or other preferences. Every mask type and style has its own strengths and weaknesses, but the explosion of variety in masks may actually not be all that it’s cracked up to be if these sleep professionals do not take advantage of all these options for their patients.
Our center is named Maimonides Sleep Arts & Sciences for a reason, being that many PAP patients (what we affectionately called “Pappers”) are just too finicky to be able to gain a consistent response without our taking them through the “art” of mask sizing and fitting. To reiterate, you cannot get this level of care in any other place except a night time experience in the sleep lab or in some cases a daytime experience with a PAP-NAP. While I certainly believe in the genuine and sincere good intentions of all members of the sleep medicine community, it’s simply impossible to expect to solve these mask issues in brief daytime encounters for a very sizeable number of cases. Yet, this approach is exactly what insurance companies are adopting by throwing up barriers that prevent patients from returning to the sleep lab.
So much of these issues revolve around the belief that patients should just be able to figures things our or they just need to try harder to figure things. And, I am not debating here that there is a large proportion of patients that easily figure these issues. Such individuals in general are more well-adjusted, individualistic and in possession of a can-do attitude. They exhibited what’s known as a very high degree of “self-efficacy.” These posts are not about these sorts of patients. Vulnerable and sensitive patients are quite different. Not only would we see them as being more dependent than independent in personality style, but in many there simply is not the dexterity or common sense to solve these problems.
Just the other day, I saw a patient who was furious with every key sleep professional in our care, including me, my staff, his DME company and the insurance company. All the problems revolved around mask replacement issues. Somehow no one had every explained to her the difference between a mask and mask cushion. The patient kept receiving mask cushions in the mail on a monthly basis, but she could not figure out what do with them and repeatedly contacted all relevant parties demanding she receive a new mask. It turned out that we only needed to show her how to pop the current cushion off the hard mask system and then seat the new cushion on in its place.
The above example is not designed to suggest someone needs to go to the sleep lab to learn how to replace mask cushions. This patient, however, had come to us from another facility, had been failing on CPAP for years, and was never accurately diagnosed and effectively treated for a leg jerk disorder, all of which required her presence in the sleep lab, where we showed her the option of the full face mask. The FFM helped her respond much better to pressurized air, and the new PAP mode (ABPAP) was much more comfortable and efficacious. We failed her though in not showing her the cushion replacement technique on the night she was in the lab.
Ultimately, we return to common sense and dexterity issues that are so critical to the success of vulnerable and sensitive patients. It may seem expensive and inefficient to resort to the sleep lab for these types of patients, but if the premise proves accurate that not using a PAP machine is almost always more expensive in the long-run compared to letting patient’s health problems worsen, then the sleep lab currently is the place to invest a great deal of time, effort and resources to place these dependent types patients onto the right treatment pathways. Still to hop on board this “sleep lab track” requires considerable negotiations with insurance carriers, although surprisingly or not, an institution such as Medicare has made the process extremely accessible as no prior authorizations are required.
Nonetheless, one of largest of all the barriers would be found among insurers applying prior authorization schemes to maneuver patients away from the sleep lab, which we believe results in inferior outcomes for the vulnerable and sensitive patients we have been discussing. The most obvious ways in which patients suffer, of course, is merely the delaying process that frequently occurs in dealing with insurance personnel. With these delays, patients’ frustrations mount and eventually some quit therapy altogether and in the process give up on the idea of ever being able to use a PAP machine. Even larger negative influences on patients are the various authorization hoops to jump through, which not only add to the delay but often lead to new and greater frustrations.
Take the example of a chinstrap. It’s very reasonable to assume that a patient with mask leak and mouth breathing problems might see great improvements with a chinstrap, which is why these add-ons are a popular remedy prescribed for many patients. But, if you’ve never worked directly with patients to fit and prescribe a chinstrap, then you may not be aware of how much time, effort and nuanced adjustments are needed to get things right. Even among my own techs, there are occasional battles where one tech started the patient on a non-adjustable chinstrap and then a few weeks or months later the patient is seen again in clinic or in the lab, and it seems clearer that the adjustable chinstrap is the better option.
Many more chinstraps are available nowadays, but there remain several fitting problems, not the least of which is determining whether a patient must use the chinstrap under the mask (atypical) or over the mask and headgear (traditional location). Just this single change could yield monumental differences. Yet, there are a proportion of cases where the chinstrap either proves irritating or painful or induces claustrophobia if it is worn outside the mask, and only after the patient learns how to apply the chinstrap first and then seats the mask atop will optimal results ensue. Though this dimension of care may seem straightforward, in fact learning how to apply chinstraps correctly, how to clean chinstraps, and how to readjust them night after night to secure a proper and comfortable fit takes more time in vulnerable and sensitive patients, which is why they must return to the sleep lab to learn all these steps.
Finally, if we return to our ultimate question of whether an insurer is acting rationally, you will see in the next post how we must attempt to traverse through these various administrative hoops to eventually secure a spot for a patient in the sleep lab to work on all the numerous and subtle obstacles that prevent them from achieving optimal responses to PAP. The question thus arises as to whether the insurer’s authorization schemes are truly an effective way to help patients move forward?