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A new approach to treating restless leg syndrome and periodic leg movement disorder

Sourced from Classic Sleep Care- A new approach to treating restless leg syndrome and periodic leg movement disorder

Last year, I noticed a worsening of my restless leg syndrome (RLS) and my periodic limb movement disorder (PLMD) symptoms. For years, I only suffered from restless legs, and maintaining my serum ferritin levels above 50 with occasional iron supplements always solved the issue. Then, I suffered a decline in the quality of my sleep and visited my own lab here in New Mexico, where we discovered scattered independent leg movements, known as PLMD. Before taking the leap to test the standard, established evidence-based drugs, I pursued two other pathways. First, I bumped up my iron levels closer to 100 as one scientific publication suggested this step might further decrease RLS/PLMD symptoms. The second approach was to bump up my Vitamin D supplements as two recent publications have suggested a connection between RLS/PLMD and low levels. Neither of these efforts made any difference in the quality of my sleep.

Before asking my primary physician to prescribe a standard medication (e.g. Mirapex, Requip, Neurontin), I elected to investigate alternative medicine literature for anything newly researched. I’ve scoured these resources frequently over the past several years hoping to find something for those patients unwilling or uninterested in attempting prescription drugs. As you probably know, you can find tons of advertisements and almost no research on alternative medicine products; and as RLS/PLMD are so common you will see lots of “endorsements” for allegedly successful remedies. Indeed, I know a fair number of patients who have tried several alternative medicine approaches, but rarely do we see documented decreases of leg jerks in the sleep lab. Moreover, rarely do patients inform us of great benefits.

In my search near the end of 2017 I found this research on L-Tyrosine and RLS. A summary of this research proposal reads as follows:

Tyrosine is a non-essential amino acid that is the precursor of the neurotransmitter, dopamine. Tyrosine is converted into Levodihydrophenylalanine (L-Dopa) and L-Dopa is subsequently and avidly converted into dopamine. It is well known that dopamine deficiency leads to the manifestations of restless legs syndrome (RLS). Studies have shown dopamine agonists and L-dopa to be effective in controlling symptoms. No studies to date have been done to determine the role of Tyrosine in RLS. This open-label pilot study aims to determine the efficacy and tolerability of tyrosine in RLS, as current agents have limitations in treating RLS in addition to adding another possible agent to the investigators arsenal of treating RLS that may be more cost efficient. In this pilot study, the dose of Tyrosine will be escalated from 750 mg once daily by mouth (PO) up to 3000 mg once daily PO, as tolerated, in increments of 750 mg every week in patients who meet the inclusion criteria for RLS. Patients’ symptoms will be monitored on a weekly basis for six weeks.

The most remarkable finding on the website is the absence of any published results. The protocol was arranged by an organization named Seton Healthcare Family in Austin, Texas. I have attempted to contact this organization to find out whether the study was ever conducted and whether any results are available. To date, I have spoken with a sleep doctor in this organization who had no knowledge of the research, but he speculated there might be a neurology group involved in the work. He indicated if he found out some new information, he would contact me.

In the protocol, you will notice they mention open-label trial, which means there is no control group. In particular, there is no placebo used in this kind of study. Instead, all patients enrolled received the same protocol of 750 mg/daily of L-Tyrosine for one week followed by weekly increases to 1500 mg, then 2250 mg, and then 3000 mg. The last dosage of 3000 mg would be in use by the patients from the 4th through the 6th week, at which point the experiment would conclude.

The study was designed to assess RLS treatment without mention of PLMD.  Nonetheless, those with RLS usually suffer from PLMD, and whatever works for RLS often works for PLMD as well. Many of the original drugs for these conditions are related to the pharmacology of the neurotransmitter dopamine, and the original agent (Sinemet) was a combination of two drugs called carbidopa/levodopa. For more than a decade, the drugs Mirapex (pramipexole) and Requip (ropinirole) have been mainstays in the fields of sleep, psychiatry, and even primary care for the treatment of RLS/PLMD.

With this backdrop, and as noted in the protocol, L-Tyrosine might be expected to work by enhancing availability of the precursors to dopamine and thus produce more dopamine. Not being a pharmacology expert, let me just say this explanation seems the most practical and coincides with the one offered in the protocol, but this theory does not preclude the possibility of other explanations for how Tyrosine might treatment leg movements or perhaps promote better sleep quality. In fact, if you explore the alternative medicine endorsements just using internet searches you will find a great deal of paradoxical information attesting that L-Tyrosine is beneficial for completely different purposes. For example, some use it for RLS/PLMD or for sleeping better, whereas others report using it in the daytime as a stimulant to decrease sleepiness and increase concentration. Others report L-Tyrosine has mood-altering properties such that it might decrease anxiety and depression. This bewildering array of effects might suggest it is a very powerful supplement, but it also might indicate contradictory evidence suggesting it doesn’t really work for anything.

Not knowing any way to judge the accuracy of these testimonials while holding a high level of suspicion for things that are advertised – but not thoroughly backed up by research, I elected to take the plunge and try L-Tyrosine for my objectively diagnosed, untreated independent leg jerks. Let me reiterate that my motivation for starting the supplement was generated by worsening of the quality of my sleep, which consistently led to degrees of daytime sleepiness and fatigue I had not experienced in years. Periodically, I have suffered minor bouts of sleepiness that often responded to changes in my masks or slight changes in my ASVAuto pressure settings. Or, in some cases, a cup of hot cocoa or green tea was sufficient to address the problem. But, the sleepiness I was now experiencing as much as two or three days in the week was sufficient to induce napping during the daytime. This degree of daytime hypersomnolence had been relatively rare for more than a decade.

The first night I selected the low dosage of L-Tyrosine 500 mg, and I can honestly report the very next morning I knew I had slept better with more dreaming that night and feeling more refreshed that morning. Given my scientific bent, I proceeded to alternate a few nights with 500 mg of L-Tyrosine and then a few nights without for about two weeks. At the end of this initial experiment, I was persuaded the benefits were positive and very noticeable. So, I went to every night use of 500 mg for the next two months, and among all the findings the most noticeable were two things. First and foremost, during the daytime, the sleepiness and napping behavior were virtually eliminated. However, the second and somewhat odd finding was the excruciating sense of deeper and more prolonged sleep inertia in the morning.  There were episodes where I would awaken in the morning and would need to remain in bed for almost an hour, probably going in and out of various stages of sleep including REM as I recall dream activity. In this first phase of use, I noticed if I got out of bed ‘too early,’ I felt the need to walk more slowly, and if I had work at the computer, my typing speed was slower and clumsier. Still, the remainder of the day brought an overall level of productivity much higher in comparison to when I was suffering from the napping behavior and fighting drowsiness.

Early this year, having used the 500 mg dosage for about 2 months, I noticed a drop off in the effects and elected to increase the dosage to 1000 mg. I immediately noticed the same levels of improvement, that is decreased napping behavior and fighting off drowsiness, both of which lasted another two months, then I noticed another drop off. In March, the dosage was increased to 1500 mg and since then I have also used 2000 mg occasionally. However, recently, I was persuaded that the effects of the larger dosages were not necessarily any better than the 1000 mg, so for the past couple weeks I only use two 500 mg pills near bedtime.

Just like many of the prescription pills advertised for RLS/PLMD, there is no sedating effect of L-Tryosine at bedtime. Using the supplement at bedtime, 30 minutes before bedtime or even 2 hours before bedtime has had no impact on when I feel sleepy prior to lights out. And, since my RLS has remained under good control with iron supplements, my theory is that L-Tyrosine is treating my PLMD only. However, given the discussion of sleep inertia in the morning, I have experimented with taking the supplements more than 30 minutes before bedtime. I do think this timing issue has some impact on the duration and depth of the sleep inertia, but I have yet to sort out a perfect system to decrease these sensations. Then again, at this point, I am not overly concerned as it is clear some portion of this inertia represents actual sleep time, almost always with my ASVAuto PAP in place, so presumably high-quality sleep. On a few occasions without the PAP, my sense is this additional slumber remains at higher quality, probably due to the ‘momentum’ effect of having used PAP for several hours before this short non-PAP period.

Regarding some of our other like-minded individuals, you may know that many patients throughout virtually all healthcare systems show strong reluctance to the use of medications and instead frequently pursue alternative medicine pathways. I was intricately involved in several alternative medicine methods and institutions for almost a decade before entering medical school, so I am very aware of how so many people look for non-allopathic or natural remedies. At our center, we see many such folks who absolutely refuse to consider prescription pharmaceuticals. I believe that some of this reluctance comes from a proportion of RLS/PLMD patients who do not believe their legs are moving during the night. In some ways, this perspective is similar to people who do not believe they suffer from any breathing events at night and therefore question the need to attempt PAP therapy. Leg jerks of course are more difficult to define as an independent disorder until breathing has been normalized with PAP therapy or some other modality. So, in the clinical setting we might be at a disadvantage with some patients who were previously reluctant to use PAP, yet now must consider adding a medication to treat their leg jerks to optimize results. In most of these cases, patients are not gaining a superlative response to PAP, largely due to the untreated PLMD. Some will have tried prescription medications and suffered numerous side-effects. Others completely reject the notion of using prescription drugs.

Some anecdotal evidence has emerged from these types of patients. Among such individuals whom informed about L-Tyrosine use, we are aware of roughly 10 patients who attempted or are attempting regular use of the supplement. For a couple patients, there was no benefit, but the remainder reported similar improvements as described myself. A common report is “I am definitely sleeping deeper.” As we retain a certain cautionary approach to this atypical recommendation for these patients, we present them with the following information inserted into their most recent sleep study reports and discuss the ideas before they make their decision to start the supplement:

Regarding leg jerks, because the patient has tried other prescription medications and may no longer be interested in pursuing such treatments, the patient may wish to consider L-Tyrosine supplements, starting at 500 mg at bedtime and increasing over several weeks to the 1000 to 1500 mg range. There is no authoritative research on the use of this supplement, but there are several references to it in the alternative medicine community, and we know of a few patients who are reporting benefits from its use. Unfortunately, information on any side-effects related to L-Tyrosine are not well established, so any patients using the supplement must use their own judgment in initiating this medication and is advised to monitor for any other changes in mental or physical health. Two side-effects that may be relevant include: (1) patients with thyroid disease may need to check their thyroid function tests when using Tyrosine; and (2) some people report increased sleep inertia when awakening in the morning. Speculatively, as Tyrosine is a precursor to dopamine, the question might arise whether this amino acid supplement would produce side-effects similar to Mirapex or Requip, both dopamine agonists, including unexpected compulsive behaviors, potentially related to shopping, gambling and sexual activity. If the supplement is effective in decreasing RLS/PLMD symptoms, we anticipate the patient would note a deeper and more consolidated sleep when used in combination with PAP therapy.

Of course, the fact that L-Tyrosine is a supplement means the chances of finding high quality research that designates the frequency of side-effects would be very low. There is also the question of tolerance or eventual diminishing returns from the supplement just like any other drug. Again, it may be difficult to find research on these topics.

In summing up, we certainly can’t declare that L-Tyrosine is safe or that it provides benefits, but it appears at this point to be a supplement that might indeed provide benefits and potentially may have an excellent safety profile. When would we find out the definitive answers to these questions? Arguably ‘never’ might be the right answer because who would choose to fund this research? I already approached one of the leading manufactures of OTC vitamins, minerals and supplements, and they politely declined, indicating they would not fund a 3rd-party researcher. From a business perspective, however, we can see their rationale, because anyone who conducts the research and proves L-Tyrosine works well in RLS/PLMD has just opened a new revenue stream for every other company that makes the supplement. A quick internet glance suggests no less than 10 major manufacturers are making L-Tyrosine currently.

Therefore, the only alternative in an alternative medicine perspective is the trial and error approach, otherwise known as the “N of 1” experiment in which you experiment on yourself. That’s the approach I have taken for myself and going forward there are two more steps I am hoping to pursue later this year. First, I want to go back into the sleep lab after maintaining a stable dose of L-Tyrosine for a several months to determine whether there is a decrease in the frequency of independent leg jerks. Second, I want to taper off or discontinue L-Tyrosine and then try one of the dopaminergic medications such as Mirapex or Requip to see whether or not the response is identical to what I have achieved with the supplement. These steps would provide me with a lot more confidence in trying to understand how L-Tyrosine might be working and whether or not it is truly working.

In the meantime, caveat emptor remains in play, but so many people refuse to attempt prescription medications for RLS/PLMD, perhaps L-Tyrosine would be something a person would try on a temporary basis to determine if relief would be forthcoming. If so, the patient would then be convinced that the leg jerks clearly need to be treated, and from that point going forward the patient will at minimum recognize that RLS/PLMD is something they need to get a leg up on in their treatment of all their sleep disorders.

A guaranteed wave of the future – Research ideas to improve the home sleep test and APAP model

Sourced from Classic Sleep Care- A guaranteed wave of the future – Research ideas to improve the home sleep test and APAP model

One of the most reliable predictions anyone could make about the field of sleep medicine is that greater reliance on home sleep testing is a guaranteed wave of the future. Although many imagine this perspective is fueled by insurers attempting to cut costs, I would argue the driving influence will eventually prove to be related to the advances in the technology. The growth in the home sleep test (HST) system right now is probably in the range of mild but steady. I do predict it will take off like a rocket ship when the technological advances profoundly upgrade the data collection to the point of matching or surpassing what is acquired in the sleep lab. We are already there for HST in diagnosing mild to moderate obstructive sleep apnea, but not for UARS, central or complex sleep apnea.

With this backdrop, my colleagues and I at our sleep research facility, the Sleep & Human Health Institute have been contemplating a number of protocols that might attempt to gauge the success of the HST/APAP model compared to traditional in-laboratory sleep medicines services. Although we believe the in-lab model is superior at present, we have been exploring ways to understand the differences in the two approaches predict what types of advances in HST or APAP (or both) would be needed to lead to a dramatic uptick in the use of home-centered care.

Although we have not initiated a new research in attempt to study this area, the experience of walking through various protocols and developing numerous hypotheses was a lot of fun and an intriguing thought experiment about the years ahead. We also believe sharing this information might prove useful to other researchers who have been thinking about how to investigate these models of care.

The general area we examined might be called a ‘Framework of Clinical Relevance’. In other words, we already know many patients are excluded from obtaining HST due to various co-morbidities while others are often required to undergo HST as the only initial step available due to insurer policies and procedures statements. In our opinion, the current guidelines are often misapplied by insurers, which then lead to poor results in numerous ways for different types of patients.

For example, as we’ve mentioned many times we work mostly with mental health patients with sleep disorders, and their rate of OSA/UARS is extraordinarily high despite patients’ intake impressions that their sleep disturbances are caused by psychological and emotional factors. This initial impression is the first reason the HST model may not work well for them. On the other hand, the argument could be made that such sensitive people might be more comfortable testing in the home than in the foreign and potentially threatening sleep lab space. However, this point begs the question, because there is an enormous interpersonal factor missing from the discussion. At home, the mental health patient is on his/her own, whereas in the lab the sleep technologist is there providing the three E’s: constant encouragement, patient-specific education, and at our center a little bit of entertainment as we have always found a value in the use of humor in this setting. A fourth factor of course is comfort. The patient can request adjustments all night long, even on a diagnostic study, to maintain comfort and eliminate any pain, distress or discomfort.

What I’ve just described about the sleep lab is a leading factor in why some sleep centers are more effective in achieving higher compliance rates than others. Simply put, any sleep center that assiduously makes their patients feel more comfortable in the lab as well as helping patients to make sense of the entire experience often achieves higher compliance rates. The HST/APAP is at a disadvantage from the outset for such patients, because no amount of education from the initial encounter to the PAP setup could possibly substitute for the experiential qualities of the in-lab protocol. And, it is for this reason, why the HST/APAP is such a great new opportunity for a less expensive delivery of higher quality care when matched to the RIGHT PATIENT!

Thus, the first research protocol we talked about attempts to tease apart who really is the right patient for HST/APAP and who might in fact be harmed by the model. Please note, the same patient who would be turned off by the HST/APAP model might also be the same patient who would hate the sleep lab, hate PAP therapy of any type, and truth be told, hate the idea of being diagnosed with a sleep disorder. That said, it is prudent for these discussions to consider the smaller yet still very sizable cohort of patients who are known as “treatment-seekers.”

Treatment-seeking patients are a doctor’s delight, because to varying degrees they have already engaged in some form or another with the diagnostic process before having entered a sleep center. They already know something is wrong with their sleep and want to do something about it. Nowadays, some patients are so advanced in their understanding that they walk in the door and ask for a home sleep test. These individuals are likely to show the highest rates of compliance, and their proportion of use should be just as high as anyone who went through the sleep lab environment, although there are exceptions to this rule that will discussed below when we delve into the differences between APAP and more advanced technologies.

It’s easy to spot these individuals. They complain about sleepiness more than virtually any other symptom, and they definitely recognize that sleepiness is more problematic to them than the feeling of tiredness or fatigue. They see and experience how sleepiness disrupts their life. And, surprisingly or not, many of them technically meet a definition for severe and chronic insomnia, but only because they suffer from multiple awakenings throughout the night. The difference (and one that is both curious and remarkable) is they roll over and go right back sleep. So, in clinical terms they really do not suffer from insomnia at all. As further evidence, these folks rarely report using a sleeping pill. Why would they? They wake up 20 or 30 times per night (and are aware of it) yet by returning to sleep so easily they do not think of themselves as ever having difficulty falling asleep at bedtime or in the middle of the night. This perspective separates them from the popular concept of insomnia in many people’s minds where there is always some complaint about falling asleep, again either at bedtime or after an awakening during the night. In sum, as long as these patients with prominent daytime sleepiness and nighttime awakenings (but not real insomnia) do not suffer from any other serious or otherwise debilitating co-occurring mental or physical illnesses, they are great candidates for HST/APAP model.

But, therein lies the problem for many mental health patients as one of the best examples of the framework of clinical relevance. Mental health patients often do not report much sleepiness, but do report a lot more fatigue. They do not suffer from only awakenings but also can’t return to sleep in the middle of the night. And, finally, they almost invariably suffer from too numerous to count co-occurring medical and psychiatric conditions, many of which are worsened through the psychosomatic process of somatosensory amplification or what we have described previously as ‘attention amplification’. This process emerges when the individual feels a symptom and then over time obsesses so much about the symptom, the symptom worsens, which leads to greater attention directed at the symptom, which then leads to more magnification or amplification of the symptom and so on. As you might imagine, these patients will react adversely to home monitoring because they will pay too much attention to the sensors on their body and will not have any support to solve the problem. In the lab they will experience even more sensors, but the big difference is the sleep technologist is there to encourage or distract the patient to settle down and complete the sleep testing process.

The prospects for attention amplification rise dramatically in the next phase of care when a mental health patient is sent home with an APAP device. And, it is at this juncture that one of the most important research protocols could be designed. Remember, if someone is a classic sleep apnea patient with high motivation to overcome sleepiness and already possesses a naturally suited ability to return to sleep when awakened, then this individual easily adapts to any problems with APAP, because they simply repeat their usual behavior—return to sleep as needed whenever they might be awakened. Mask shifts? No problem: adjust and go back to sleep. Mask leaks? No problem: tighten a strap and go back to sleep. Pressure too high? No problem: hit the ramp button and go back to sleep. But, mental health patients engage in the opposite behavior. Not only would they awaken from all the oddities of masks and pressurized air and not return to sleep, but they would further magnify the problems by paying too much attention to the pressures and masks and eventually rip off the device consciously or unconsciously.

These scenarios are the ones that got us thinking about the HST/APAP model of care, because we were dealing with a particular insurer who pretty much insists on nearly 100% of its patients starting with HST. When we attempt to explain to them the flawed analysis they use to make these determinations, they have only been able to respond with questions about cardiovascular disease, physical incapacities or cognitive impairment that would prevent the patient from attempting the diagnostic HST model or the prescription for the at-home APAP device without testing in the sleep lab. Because anxiety specifically is not accepted as cognitive impairment within the insurer’s policies as a contra-indication for HST, we cannot persuade this insurance company of the value of switching back to in-lab testing.

Let me pause here and provide an anecdote of how these problems play out. The irony in the following patient story is that it would seem so obvious HST/APAP should have been the best model of care, but instead it turned into a nightmare that delayed the patient’s receiving adequate treatment for more than one year. The patient was highly resistant to the whole process from the beginning and was only pursuing treatment at his wife’s urging. Once he got the diagnosis of severe OSA via HST, he was not thrilled about trying APAP but agreed to start it. Over many months of effort, he never became a regular user, and often reported ripping off the mask during the night. Eventually, he described the process as traumatizing and exhausting, because he believed his sleep was now worsening. As such, he stopped using device altogether and made very clear he would never attempt PAP again. Many more months passed, and he finally attempted the device one more time to gain sufficient data for an appointment at the center so we could examine a data download. Prior to this encounter, the patient had rejected recommendations to seek care and support at the center, because he was too busy at work. Finally, with the download in hand it was obvious he was experiencing residual breathing events including central apneas on the APAP device, which of course bought him a ticket to undergo testing in the sleep lab to determine whether advanced PAP technology such as ABPAP or ASV would be more suited to his needs.

The night in the lab did show he had sufficient central apneas to qualify for the diagnosis of complex sleep apnea, and he was treated with ASV therapy. However, and this is the key point of the anecdote, the patient’s negative experiences with APAP remained so fresh in his mind that he could not tolerate ASV either, even though objectively the airflow signal was clearly improved with this advanced device. The ensuing months of care and support required several more steps in the treatment regimen including aggressive management of chronic congestion and medications for leg jerks, but even with these additions the patient still continued to complain about pressurized air. Finally, more than one year after the process had started and failed primarily due to the initial and problematic introduction to PAP via the APAP device, the patient woke up to the necessity of how badly his sleep was affecting him and his mental and physical health. He is now using his ASV device with more consistency and some benefit, but the results are not optimal. And, there is no question that the patient’s level of reluctance in the first place contributed to his long-term struggles and his tendency toward rejection of the treatment.

Now the argument could certainly be made and research could study whether or not effective coaching beforehand could have solved this problem. But, in our opinion this type of patient is very difficult for not only a sleep center to manage but more importantly these types of anxious patients do not work seamlessly with DMEs attempting HST/APAP models. But let’s be clear, the insurer provided no flexibility, so the patient was required to start with HST and afterwards was required to start with APAP. Yet, from the above description, this patient needed far too much hands-on coaching, therapy and clinical management at the level provided at a sleep center, but even then the results might still have been problematic. And, the research could actually test out this theory to show which types of reluctant patients can do okay with HST/APAP and which types would do better starting in the sleep lab. This protocol can readily be constructed as a controlled trial where anxious and reluctant patients are randomized to either HST/APAP versus sleep center/in-lab operations. Unfortunately, to our knowledge no insurance carrier has offered to fund such a study to find out how best to match patients to the most suitable model of care.

Another obvious approach might be a pathway where a patient is switched quickly from APAP to say ABPAP within days or a couple weeks of starting treatment. As a reminder despite the fact that APAP auto-adjusts, it is still fixed pressurized air for any given breath in time and space on both inspiration and expiration. Thus APAP still carries a higher risk for claustrophobia or panicky responses in susceptible patients. And, even if expiratory pressure relief systems (EPR) are implemented for a patient on APAP, the relief is nowhere near as effective as a bilevel device. This point, then relates back to the earlier caveat I mentioned above where the distinction between APAP and bilevel type devices may have a huge impact on certain patients, and in our opinion, a much greater proportion of cases than most sleep professionals recognize. In fact, I would argue strongly in favor of sending patients home with ABPAP devices instead of APAP devices and expect this approach to be another component of the wave of the future.

In this model of care, the DME company or whomever is the supplier of the PAP equipment would actually test the patient at their facilities to determine whether the expiratory pressure intolerance problem merits supplanting APAP with ABPAP. Unfortunately, to my knowledge this approach would be a nonstarter with many if not all insurers. Because they know so little about bilevel modes in general, their knee-jerk reaction would be that bilevel devices and especially auto-bilevel (ABPAP) are too expensive as an initial device. Yet, here we see another ripe area for research. The controlled study could be randomized into the patients receiving APAP versus ABPAP, but a major snag in this protocol is that we object strongly to the idea you can use default settings in either of these devices. We believe both APAP and ABPAP users benefit from in-lab titration studies to fine tune pressure settings prior to setup. Nonetheless, it is what it is with insurer companies, and our in-lab recommendation would defeat their purposes to keep costs down. Thus, another variant of a research protocol would be to determine the differences between APAP set to default APAP versus patients completing in an in-lab APAP experience. Then, repeat the same experiment with ABPAP at default versus in-lab ABPAP prior to setup.

As discussed above, this type of protocol would still have a major confound, because above and beyond the determination of pressure settings, we remain persuaded that the in-lab experience of working with a sleep technologist who makes subtle adjustments and provides intimate coaching during the entire process is really a priceless bonus that creates so much more momentum in patients setting out on their PAP quest.

Finally, along the same lines, we have had many centers contact us about using an in-lab PAP-NAP experience after the initial diagnostic HST but before the patient goes home with the APAP device. We would strongly encourage sleep centers to follow this pathway, because the PAP-NAP test drive is often successful in allowing PAP to put its best foot forward, so to speak. Usually, 90% or more of patients undergoing the PAP-NAP report the experience was far less troublesome than they had imagined. Most likely these results obtain because a PAP-NAP comprises one on one coaching from 2 to 4 hours including an extensive desensitization period specifically designed to help patients overcome attention amplification as well as a sleep period where the patient often falls asleep and thereby feels a great sense of achievement for doing something they never thought possible (“sleeping with a crazy mask on my face”). Of course, this protocol would be advantageous to all institutions involved in sleep care, because the PAP-NAP reimburses at about half the rate of a full sleep study, so the insurers should be pleased with the cost-savings; and, if it turned out the PAP-NAP test drive actually leads to higher compliance rates and perhaps faster compliance, then clearly it would be a win-win-win situation. Researching the PAP-NAP in this manner seems like such an obvious protocol, but again we do not know of or hear about funding resources directed at this innovative protocol.

Based on the above, you can see that the HST/APAP model still has a ways to go to catch up to the in-lab model, but I have a lot of confidence that we will see changes in BPAP, ABPAP and even ASV modes of therapy probably within a few years if not sooner that will dramatically lead to better auto-adjusting technology, which then would open the door for more patients to be eligible for a more effective response to a home-centered approach. Even today, we could see a rapid improvement in quality of care if the insurers would show greater interest in the ABPAP devices. And, while these research projects certainly might show superiority of the in-lab approach to HST/APAP, the knowledge gained will rapidly disseminate back to PAP manufacturers and other entrepreneurs that will engage them to make faster modifications.

By the way, in closing, I would like to mention that I’ve been invited to sit on a three-person webinar presentation coming up at the end of May on the topic of using advanced PAP devices. The program is put on by Sleep Review magazine and you canregister at their site.

It’s a free, three part program that delves into:

  • What the research says about compliance on CPAP versus auto-bilevel PAP and ASV in specific patient populations.
  • Practical advice for when and how to switch sleep apnea patients to more advanced therapy modes.
  • Reimbursement guidelines and how to provide required documentation for payor reimbursement of advanced PAP.

My role will be to discuss the middle part given all of our experience and publications on the use of auto-adjusting technology manually titrated in the sleep lab. I will discuss some of the signs and indications that a sleep professional can use to consider the potential value of switching a patient to an advanced PAP mode. And, some of the discussion may cross-over into the realm of how to encourage the use of these advanced devices in patients failing CPAP or APAP devices thru the HST model.

So Long to Solo Practice Medicine

Sourced from Classic Sleep Care- So Long to Solo Practice Medicine

In a very recent issue of JAMA, I was reading about the general problem of the decline in small medical practices, “Can Small Physician Practices Survive? Sharing Services as a Path to Viability.”(1) Although the scope of this article is more concerned about the use of new resource models that would help small practices stay afloat, the beginning sections of the commentary speak about the very important topic of quality of care. After describing briefly a few of the examples the authors provide, I will illustrate how these ideas directly affect small vs larger sleep medicine practices.

The first data point is the decline in solo practitioners from 1983 to 2014, a drop from 44% to 19%. In contrast, in 2015 34% of all doctors were in practices involving 100 or more physicians. These changes are dramatic to say the least, and the trends certainly do not bode well for solo docs. I worked in an academic medical setting from 1979 to 2000, and then I switched to solo practice 18 years ago. All around me, I see a dwindling supply of solo practitioners in various fields of medicine. In New Mexico, I am not certain of the actual count, but I believe there may only be a handful or fewer solo sleep medicine specialists. The largest proportion of sleep patients are served by large hospital centers, academic, or community-based facilities. All these sites have three or more sleep doctors, and most have several mid-level professionals in the form of physician assistants and nurse practitioners. By definition, some of these practices are still considered small, but then again they are still influenced by larger administrative bureaucracies that impact quality and delivery of care.

The second and main data points address quality of care in ways that may or may not be surprising. In one study, a comparison looked at practices of only 1 to 2 docs versus practices with 10 to 19 docs and found that the smaller groups demonstrated a 33% lower rate of preventable hospital admissions. Small practices of only 3 to 9 docs showed a 27% lower rate of preventable hospital admissions compared to larger practice groups. Presumably, “preventable” simply meant various factors in the examined caseloads that could have been identified and managed to prevent the hospitalizations, and the smaller practices were far better at this form of management. Another study looked at a very wide spectrum of practices measured from 5 to 750 doctors. Not only were the smaller practices better again with lower rates of hospitalizations but also better in keeping costs lower in managing diabetic patients.

Can you guess why?

The commentary does not address this issue other than to indirectly suggest that the “personal touch” had something to do with these better and cheaper outcomes. There are probably a lot of different reasons, but one that jumps immediately to mind might be as simple as the type of person who stays in solo private practice in this day and age of aggregate data, if not aggregate doctors. One of the big ideas about BIG DATA is the belief that with so much information, the probability is increased of finding out so many more things about entire populations that eventually the insights filter down into specific patient situations. However, the conclusions drawn from aggregated data may sometimes end up serving a purpose that places financial or expedient aspects over quality of care.

Consider the inception of home sleep testing. As HST cannot provide the same amount of information as a polysomnogram, why would insurers promote this model of care? The answer is not just a straightforward cost-analysis. Rather, entrepreneurs who invented HST devices looked at the big picture and realized that an enormous number of patients could be diagnosed with sleep apnea without ever having to know what was transpiring in their sleep patterns. Yes, there is tremendous irony in the fact that a homesleep test usually is not measuring sleep at all. Instead, it measures a sufficient amount of information regarding breathing and oxygenation to reliably detect the presence of a sleep breathing disorder. And, even though my colleagues and I want to see more sleep specific information (EEG brain waves) to actually measure the important variables of sleep stages and sleep fragmentation, we cannot deny the HST model provides a clear-cut tool for diagnosis OSA in specific cases. Some of these devices purport to test for UARS as well.

Thus, this BIG DATA idea that you can detect and measure the severity of the diagnosis of OSA without knowing what’s going on with the patient’s sleep has had a major impact on the field of sleep medicine. Nowadays, HST provokes a lot of controversy not to mention a great deal of struggle between sleep centers and insurers, whenever the necessity for more in-depth sleep information is in play. No doubt, technology will solve this problem as well, probably sooner than later, as HST devices become more sophisticated, but that’s another story.

Think of the potential impact of HST on solo practitioners. On the one hand, this model of care has actually driven some private practice doctors into retirement (and closed some academic centers as well), because these sleep professionals were situated in an environment where their particular insurance companies rapidly instituted policies promoting and then demanding HST’s. If a solo practitioner or any other sleep doc for that matter had to rely on some proportion of cases tested in the sleep lab, then as soon as the number drops below that percentage, the practice may no longer have been financially viable.

When I was growing up in the 1950s and 1960s, a common expression of the day was, “You can’t fight city hall.” It’s just as relevant today as government in many places continues to expand and create more and more rules and regulations about everything in our lives. The same paradigm seems to have taken hold of the insurance companies who often dictate what actually occurs in sleep medicine practices in many parts of the USA. Again, how long could a solo practice physician fight with insurers to maintain their necessary financial status as well as maintain a level of quality of care perceived as necessary and appropriate? Take the specific example of the prior or pre-authorization process, which wastes enormous amounts of time, energy, resources and money in attempting to schedule patients in a sleep center. The expanding prior authorization paradigm is already curtailing practices patterns in numerous ways, including increases costs while decreasing revenue.

Return to the specific effects on solo practice, keep in mind that many solo practice physicians are probably one of two overlapping types. They might be more curious and creative about looking at new or advanced ways to provide care to their patients, and they might be less comfortable with other doctors let alone administrators breathing down their necks telling them how to manage patient care. I suspect both perspectives are common in physicians who end up in solo practice. I do recall both factors influencing my decision to go into private practice by myself following several waxing and waning struggles with the bureaucracy of university environments. And, because I had the good fortune to learn so much about research in the university environment, I found I could eventually bring that mindset into my private clinical practice of sleep medicine to enrich my work experience and more importantly create new ways of evaluating and treating my patients. What I learned greatly expanded how I treated several of the most common sleep disorders, primarily OSA/UARS, insomnia and nightmares.

Indeed, one of the greatest joys in my medical career has been to involve myself in researching both the patients who seek care at our center in New Mexico, along with the occasional research cohorts we recruited for smaller projects. This combination of activity, which generally falls into the retrospective (that is, simple chart reviews) and prospective (that is, a formal project where we seek Institutional Review Board approval) designs and has enabled us to learn so many things to apply in helping our patients sleep better. For instance, we had the opportunity to work with so many mental health patients with sleep disorders, we were inundated with the problem of CPAP failure, which in turn pressured us into looking for another solution. Once we latched onto the bilevel devices, we immediately found ourselves developing a new paradigm to monitor and resolve the problem of expiratory pressure intolerance. Simultaneous to these experiences, we realized contrary to the conventional wisdom that many insomniacs could in fact use PAP therapy, just not CPAP. Instead, by switching them to bilevel devices not only could they adapt and adhere to pressurized air flow, it actually decreased their insomnia more so than standard CPAP or APAP devices.

These two pieces of information radically changed the way in which we practiced sleep medicine, and then a third concept arose between 2008 and 2010 when we starting using even more advanced bilevel devices like ABPAP and ASV. We realized we could manually titrate these modes in the sleep lab to provide an even better response than simply using their auto-adjusting capabilities without the added human factor of a sleep technologist over-riding the device.

We were also fortunate to have the good sense to hire individuals with more creative bents to work in our front offices and in our sleep lab. And, all told there were four individuals who worked as sleep technologists and who at various points put in major efforts in sleep research at our non-profit Sleep & Human Health Institute. In total, their efforts comprised somewhere around 30 years of combined work. Several other sleep technologists put in part-time efforts totaling another 10 years of research experience.

All these process unfolded in the context of having some degree of free rein a private practice system and which further enabled us to open up and fund our non-profit institute. This creative component in myself and in the personalities of more than half of my staff greatly influenced our desire and motivation to remain in solo practice.

Other solo practitioners may operate with different aspects of creativity. For example, I have noticed many primary care physicians develop niche practices where they can provide competitive services in managing complex disease processes like diabetes such that their patients rarely if ever need consultations with endocrinologists. The same has proven clearly to be the case with many primary care physicians practicing elements of psychiatry in the management of psychotropic medications. None of these efforts guarantee that all these solo practices are the best they could possibly be. Likewise, I cannot say that I would not have benefited by engaging with other sleep doctors had they been more closely available to my practice setting. Though I meet with many sleep physicians in numerous venues throughout any given year, such encounters are far different than working in the trenches with another physician. For these reasons, some doctors forego solo practice, but are quite happy in groups of 2 to 3 physicians.

It appears solo practices are a dying breed. My sense is this trend will be a bad thing, because it will likely lead to more groupthink as naturally occurs in larger institutional settings, such as seen in hospital practices. But, however things evolve, healthcare in general and sleep medicine in particular are certainly in for a great many fluctuations in how to deliver healthcare.

_______

References:

(1) Khullar D, Burke GC, Casalino LP. Can Small Physician Practices Survive? Sharing Services as a Path to Viability. JAMA. 2018 Apr 3;319(13):1321-1322. doi: 10.1001/jama.2017.21704.

The Southern Sleep Society 2018 (Part II) – Dr. Krakow’s lectures on PTSD and CPAP compliance gain attention among top sleep professionals.

Sourced from Classic Sleep Care- The Southern Sleep Society 2018 (Part II) – Dr. Krakow’s lectures on PTSD and CPAP compliance gain attention among top sleep professionals.

During my last blog post on the Classic SleepCast for Classic SleepCare, I discussed how I was invited to deliver two talks on sleep at the Southern Sleep Society’s 40th annual meeting. I will also be doing the same lectures during the September Sleep 2018 meeting as well. My talks delved into the “PTSD Sleep Clinic and Nightmare Triad Syndrome” and “Advanced PAP Therapy to Increase Compliance and Decrease Insomnia.” Both talks were received very well and sparked a number of discussions afterwards with several of my colleagues and other attendees. Several key points were offered in my talks, and my last post used a bullet point summary to make you aware of the most relevant.

In that post, I also discussed how an atypical presentation of OSA/UARS in an insomniac often leads to the use of advanced PAP devices at our sleep center in New Mexico. Now, I want to delve into this same issue but we will be looking at the point of view where someone is prevented from obtaining an advanced PAP mode. And, this barrier to the use of advanced PAP almost always relates to the current confusion about the core concept of CPAP failure, something we have discussed in this blog previously.

A recurring theme from attendees who approached me after each of the talks were the difficulties, hassles, and obstinacy encountered when dealing with insurers to clarify the notion of CPAP failure as well as to gain approval for advanced PAP devices. Some of these sleep professionals clearly perceived their insurers as the major obstacle as they pointed out the near impossibility of even obtaining a simple bilevel device for their patients failing CPAP. So, let’s summarize this vicious circle with a few bullet points before we dig deeper into the details:

  • An astronomically high number of patients do not like CPAP; we know this reaction to be true because as much as one-half of all ‘CPAP attempters’ quit – so there must have been something about CPAP that made them quit.
  • Sleep doctors and sleep technologists observe this de facto CPAP failure all the time in clinics or in the labs or in communication with DME companies.
  • Yet, when sleep center staff approach insurance companies to rectify the situation by promoting the implementation of a more advanced device, even something as simple as bilevel, these insurers will often balk by using twisted rules to prevent any efforts in helping the patient.
  • The sleep doctors, techs, and staff attempt to explain to the insurers how the patient is failing CPAP.
  • But the insurers keep bringing up various factors, which according to their rule book, must be addressed before someone can get a 2nd or 3rd or 4th chance at a different device.
  • These rules seem straightforward. If the leak has not resolved, get a new mask; if dry mouth remains an issue, prescribe a chinstrap; if leg jerks are a problem, treat them with medications. And, all these steps are usually attempted but they do not always yield stellar results. My favorite rule is the one where the patient cannot reach standard compliance numbers of 4 hours per night for 5 nights per week, and then the insurer’s medical director informs me the patient “needs to try harder.” This set of rules is how an insurer often prevents patients from ever seeing the light of day in a sleep lab, where individuals could try bilevel, discover greater benefits, and then expect to receive a prescription for a BPAP device.
  • With some insurers, you can eventually get them to agree with in-lab sleep testing, which is the best chance a sleep center gets to demonstrate the value of advanced PAP in a struggling individual.
  • However, it is very clear some insurers absolutely never want their beneficiaries (don’t you love that word) to ever get into the lab, not only because of the expense, but also because the insurer knows the patient might be exposed to an advanced PAP mode (insurer’s read that as ‘a more expensive PAP mode’) regardless of whether this patient might appreciate a noticeably better response.
  • Finally, if a center is fortunate enough to build the case for the patient to return to the sleep lab, then the definition of CPAP failure enters into the equation in ways that many sleep professionals do not appear to know how work through to move beyond standard CPAP therapy.

Let’s continue with this discussion of CPAP failure. As we have discussed numerous times in the past, a sleep tech and the supervising sleep doctor must be able to recognize expiratory pressure intolerance as it emerges while that patient’s fixed CPAP pressures are increased to attempt to eliminate RERAs. These two concepts should prove to be the chief variables in defining CPAP failure in the overwhelming majority of cases when such a problem needs to be documented in the sleep lab.

But therein lies part of the problem. Since so much imprecise information has been written on the topic of CPAP failure, no one really knows for sure what it means. In the olden days, back in the 1980s and part of the 1990s, there was a belief that the only way you could fail CPAP was to take it home and try to use it. When you returned and showed non-compliant data you were said to have failed the device. Keep in mind that one of the major scenarios in play back occurred when a patient wanted surgery or maybe a dental device, so they needed to “fail” CPAP to gain insurance coverage for these other treatment options. Many of these patients simply brought their CPAP devices home and found a very comfortable and stable resting place for the machines in their closets. Three months later, they returned to the sleep center to gain the “CPAP failure designation” and then proceed with surgery or OAT.

To my knowledge, there may be some insurers who still insist the patient must try CPAP at home in order to achieve failure status. However, over the past 15 years we have observed and routinely implemented a different approach based on what occurs upon exposure to CPAP in the sleep lab. As mentioned in prior posts, our sleep center in New Mexico specializes in mental health patients with sleep disorders, which often included some degree of anxious feelings (e.g. claustrophobia, panic, anxiety attacks) related to sleep problems in general or sleep apnea/PAP in particular. Thus, we got to know first-hand 15 years ago many of these patients were struggling with and hating CPAP and very much needed an alternative form of PAP.

Their rejection of CPAP in the sleep lab was then designated CPAP failure, because in so many of the cases patients were either freaking out while attempting fixed pressure or reporting a great deal of discomfort akin to the “drowning in air” metaphor. Either of these scenarios can be deemed CPAP failure, and we have used them successfully to punch the patient’s ticket for a night in the lab.

In my discussions with the sleep professionals at the Southern Sleep Society conference, it was very clear that many doctors or techs were just not clear how they could push the envelope in this fashion for the benefit of their patients. I spent a fair amount of time discussing this phenomenon and showing graphics to demonstrate how efforts to raise pressures to resolve RERAs would result in EPI, and that EPI is almost universally the core factor in patient discomfort that leads to outright CPAP rejection or sufficient CPAP discomfort to consider it as a failure case.

However, most sleep technologists are not trained to be looking at the expiratory limb of the airflow curve once apneas have been eliminated. Instead, the focus turns toward the inspiratory limb to eliminate hypopneas. At some sleep centers, this progression continues in an attempt to eliminate RERAs, but as the pressures increase toward this objective, the expiratory limb starts to change and frequently shows irregularities – suggesting the patient is fighting with the pressurized air. The simplest explanation for this struggle is the unnatural feeling of trying to breathe out against incoming air. The sensation is probably most analogous to sticking your head out the window of car driving 60 mph and then expecting to have an easy time breathing against the strong wind created by moving vehicle. Even inspiration can feel odd with this much air blowing inwards, but with certainty we can tell you that expiration for most of these patients feels very odd indeed.

These experiences appear to be occurring among many CPAP users, but at varying degrees of intensity, such that some patients eventually adapt to CPAP at home whereas others give up on CPAP from the word “go.” Because there is no clear-cut definition for CPAP failure a lot of sleep professionals are at a loss on how to proceed. Few recommend retitrations. Some ask their patients to take a break and start again. Others recommend trying to use new masks, chinstraps, nasal pads, mask liners and so on, yet only a very small proportion directly address the problem of higher pressures needing to treat RERAs, which then aggravates expiratory pressure intolerance. Moreover, there seems to be little discussion within the sleep community on how the auto-adjusting mode of something like an ABPAP device can facilitate the treatment of RERAs without triggering EPI. Ultimately, because there also remains a lack of clarity on the true components of normal sleep breathing, all these barriers converge to prevent providers from even considering advanced PAP devices for most of their CPAP failure cases.

 

The Southern Sleep Society 2018 – Dr. Krakow’s lectures on PTSD and CPAP compliance gain attention among top sleep professionals.

Sourced from Classic Sleep Care- The Southern Sleep Society 2018 – Dr. Krakow’s lectures on PTSD and CPAP compliance gain attention among top sleep professionals.

This year I was invited to deliver two talks at the one of the oldest annual sleep society conferences, The Southern Sleep Society, at their 40th annual meeting. My talks delved into the “PTSD Sleep Clinic and Nightmare Triad Syndrome” and “Advanced PAP Therapy to Increase Compliance and Decrease Insomnia.” Both talks were received very well and sparked a number of discussions afterwards with several of my colleagues and other attendees. I would like to describe some of the hot topics that were broached from the comments and questions that emerged.

Several key points were offered in my talks and this bullet point summary will cover the most important ones. The first talk covered PTSD topics:

  • In mental health circles, psychiatrists, psychologist and therapists still use the terminology of “sleep disturbances” when it should now be evident that mental health patients suffer from independent or co-morbid sleep disorders.
  • This sleep disorders distinction is highly relevant in the clinical environment, because PTSD patients in particular and mental health patients in general, are frequently receiving sub-standard care due to the lack of evidenced-based assessment and treatment of their sleep disorders.
  • Sleep professionals have a great deal to offer the mental health community. Including patients and professionals in providing the highest possible quality of sleep care because of our greater understanding about sleep disorders and our capacity to treat them.
  • Therefore, sleep professionals need not be defensive in attempting to help the mental health community – it makes the transition to more actively treating sleep disorders in their patients.
  • ‘The Nightmare Triad Syndrome’ is a prime example of this phenomenon, where in the past diagnostic criteria for PTSD included nightmares and insomnia as symptoms. Now, not only are the nightmares and insomnia recognized as independent treatable disorders in most trauma survivors, but sleep-disordered breathing in the form of OSA or UARS completes the triad and appears to occur with great frequency.
  • Treatment of any and all of these three common sleep disorders not only improves the sleep of PTSD patients, but all evidence to date strongly demonstrates (nightmares, insomnia) or suggests (OSA, UARS) that PTSD symptom severity decreases as well.
  • A key factor in these relationships appears to be how REM sleep manifests in sleep disorders patients. When REM is highly fragmented it not only worsens sleep disorders, but it appears to create a risk for developing PTSD. When REM sleep attains greater consolidation following evidence-based treatments, it appears to be associated with better outcomes.

The second talk delved into our work on advanced PAP therapy and compliance, including a discussion of many of our recent papers and current research projects:

  • Initially, segueing from the first talk, we looked at a couple of research groups who in the 1980s and 1990s predicted there would be a very strong relationship between REM sleep in the context of sleep-disordered breathing as a highly relevant clinical factor in PTSD patients.(1,2) This introduction concluded with Ali El-Solh’s recent work showing the correlation between increasing CPAP hours of use and decreasing PTSD symptoms.(3)
  • As part of this introduction, we briefly summarized our two most recent publications in which we demonstrated a strong association between the use of ABPAP or ASV in overcoming CPAP failure in general and PAP failure in PTSD patients in particular.(4, 5)
  • The cardinal principles underlying our work were described as a fastidious effort to normalize the airflow curve in OSA/UARS patients, which means aggressively targeting RERAs (flow limitation events) without triggering the problem of expiratory pressure intolerance.
  • Many examples were then provided showing how this fine tuning of the airflow curve (“rounding” on inspiration and expiration) leads to greater REM consolidation and better outcomes, including greater levels of PAP compliance.
  • Additional data were presented on our older and more recent work showing the benefits of advanced PAP on insomnia outcomes and in particular the potential advantages of ASV over CPAP in chronic insomnia disorder cases, including sleep onset insomnia as well as overall insomnia severity.(6-8)
  • In the current manuscript we are preparing for publication, we will show how the patients we recruited for the sample were unequivocally of a type consistent with chronic insomnia patients who present to primary care and mental health clinics. That is, they were not sleepy, overweight or complaining of sleep breathing symptoms. More importantly, they did report all manner of psychological symptoms and behavioral patterns typically described by chronic insomniacs. Creating a sample of this type means we were not looking at OSA patients who also had insomnia. Rather, we were looking at insomnia patients who never suspected they suffered from sleep breathing disorders. This approach means the research findings are highly relevant to other clinical populations where insomnia almost invariably presents with the focus on these psychological and behavioral issues. This elaboration also explains why it is has been so difficult for non-sleep specialists to recognize the OSA/UARS co-morbidity as only the insomnia problem is immediately visible to them during clinical encounters.
  • Finally, we delved into a new measuring tool we have begun using, “Normal Sleep Breathing Time” (NSBT), which is derived from starting with a patient’s total sleep time and subtracting out all the minutes of breathing-disrupted sleep fragmentation. What remains is NSBT, and our research shows that ASV patients had a larger percentage of normal sleep breathing than CPAP patients. We will speculate on whether this finding might explain why ASV patients report greater improvements in sleep quality compared to CPAP patients.

With this backdrop, several issues and questions were raised regarding familiar themes to anyone who reads this blog. And, unsurprisingly, there was a mixture of clinical and administrative (i.e. insurer barriers) concerns that were at the heart of most questions.

A large over-riding question and concern was how to deal with the insurers’ growing restrictions on the field of sleep medicine generally and on diagnostic/therapeutic decision-making for OSA specifically. Many individuals reported that they are seeing Medicare-creep, wherein the restrictive diagnostic criteria for other insurers increasingly embrace OSA. The two most obvious examples are the complete rejection of any recognition to the RERA scoring algorithms, that is, the flow limitation events of UARS and the further narrowing of hypopnea definitions by focusing on the 4% oxygen desaturation criteria. Though no one really knows with certainty how many people are being denied care for their OSA/UARS diagnoses due to these narrowly defined parameters, I have always assumed the proportion of cases who would meet eligibility with broader definitions numbers in the millions and potentially the tens of millions.

One of the critical facets to these issues is the conventional wisdom that continues to describe something called, “mild OSA” as a condition for which treatment is allegedly controversial. The problem with the construct of “mild OSA,” in my opinion, is that such cases rarely exist when a sleep professional takes into account either the full burden of the sleep breathing condition measured on a sleep study or the full burden the patient is reporting regarding daytime and nighttime symptoms.

Let’s examine the latter first. Suppose you are treating a young adult, female patient with so-called mild OSA, and who also reports extremely vexing nighttime insomnia. She also has a current psychiatric history of severe anxiety and PTSD, and both her sleeplessness and mental health are drastically curtailing her work productivity let alone her capacity to actually work full-time. Adding insult to injury she awakens twice per night due to nocturia episodes, and on each occasion she reports losing at least another hour of sleep trying to return to the Land of Nod. Not infrequently, she must use a sedative after the 2nd trip to the bathroom, which necessitates losing the first half of a day’s work. When she does arrive at work, the irritation in her employer’s face and voice increases her anxiety levels and further compromises her productivity. She knows the only reason she’s kept her job is she’s a very talented web designer who provides valuable services to the marketing department, but she worries about losing her job on a weekly basis and borders on panic whenever she notices her employer conducting job interviews.

Though the above is a relative composite for the sake of clarity, I have treated thousands of patients with very similar circumstances where the individual’s friends, family members and co-workers just don’t appreciate the distressing nature and impairing effects of insomnia. Such patients spend years trying out various medications, and when they finally make it to a sleep center, the sleep study is read out as “normal, borderline sleep apnea, or mild sleep apnea.” The patient is then told to avoid sleeping on her back and use good nasal hygiene. Instead, the main focus of the treatment could be:

1) Find a good therapist

2) Find the right prescription medication from your primary care physician

3) If lucky enough, return to our center for cognitive-behavioral therapy for insomnia (CBT-I).

The last of these, of course, is widely unavailable at most sleep centers. What is our (Maimonides Sleep Arts & Science) treatment approach to these patients? Quite simple. We first diagnose them properly with the UARS component of their mild OSA and explain that they essentially experience no normal sleep breathing the entire night. We then explain the connection between OSA/UARS and nocturia, a topic mentioned on this blog on various relevant posts, and at my recent TEDx talk. The patient then returns for a titration study where she quickly fails CPAP because of the problem of expiratory pressure intolerance. Switched over to a bilevel (BPAP), auto-bilevel (ABPAP) or as appropriate to adaptive servo-ventilation (ASV) PAP mode, the patient experiences the highest quality of slumber she’s felt in a decade. In fact, the effects of PAP are so dramatic, she reports vivid dreaming for the first time in years; and, she is astonished by the fact that she never awakened to use the bathroom.

As I noted at the conference, this relationship between insomnia and sleep breathing does NOT mean a patient will cure insomnia only with PAP. To be sure, many of these patients still need psychotherapy or CBT-I or both, and some still need medications. But, for starters, this patient’s life can be completely turned around by eliminating her nocturia, and these results have short and long-term benefits. Last, the patient understands experientially and intellectually why the construct of “mild OSA” was largely inaccurate in assessing her condition just on the basis of the nocturia angle for starters. Several of these points are frequently omitted throughout clinical care models for chronic insomnia provided within the field of sleep medicine, and as our discussion continues we will describe other similar perplexing trends.

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References

  1. Reynolds CF 3rd, Coble PA, Spiker DG, Neil JF, Holzer BC, Kupfer DJ. Prevalence of sleep apnea and nocturnal myoclonus in major affective disorders: clinical and polysomnographic findings. J Nerv Ment Dis. 1982 Sep;170(9):565-7.
  2. Youakim JM1, Doghramji K, Schutte SL. Psychosomatics. Posttraumatic stress disorder and obstructive sleep apnea syndrome. 1998 Mar-Apr;39(2):168-71.
  3. El-Solh AA, Vermont L, Homish GG, Kufel T. The effect of continuous positive airway pressure on post-traumatic stress disorder symptoms in veterans with post-traumatic stress disorder and obstructive sleep apnea: a prospective study. Sleep Med. 2017 May;33:145-150.
  4. Krakow B, Ulibarri VA, McIver ND, Yonemoto C, Tidler A, Obando J, Foley-Shea MR, Ornelas J, Dawson S. Reversal of PAP Failure With the REPAP Protocol. Respir Care. 2017 Apr;62(4):396-408.
  5. Krakow BJ, Obando JJ, Ulibarri VA, McIver ND. Positive airway pressure adherence and subthreshold adherence in posttraumatic stress disorder patients with comorbid sleep apnea. Patient Prefer Adherence. 2017 Nov 20;11:1923-1932.
  6. Krakow B, Ulibarri VA, Romero EA, Thomas RJ, McIver ND. Adaptive servo-ventilation therapy in a case series of patients with co-morbid insomnia and sleep apnea. Journal of Sleep Disorders: Treatment and Care 2013;2:1-10.
  7. Krakow B, Ulibarri VA, McIver ND, Nadorff MR.A Novel Therapy for Chronic Sleep-Onset Insomnia: A Retrospective, Nonrandomized Controlled Study of Auto-Adjusting, Dual-Level, Positive Airway Pressure Technology. Prim Care Companion CNS Disord. 2016 Sep 29;18(5).
  8. Krakow B, McIver ND, Ulibarri VA, Nadorff MR. Retrospective, nonrandomized controlled study on autoadjusting, dual-pressure positive airway pressure therapy for a consecutive series of complex insomnia disorder patients. Nat Sci Sleep. 2017 Mar 10;9:81-95.

Increasing Compliance with Advanced PAP Therapy in PTSD Patients

Sourced from Classic Sleep Care- Increasing Compliance with Advanced PAP Therapy in PTSD Patients

Our co-authored (Krakow, Obando, Ulibarri, McIver) paper on PTSD and PAP compliance which was recently published, provides me with the opportunity to delve more deeply into the nuances of the research paper itself. To my knowledge, this paper represents a milestone in demonstrating (for the first time) that trauma survivors appear to adapt easier and use more consistently advanced PAP devices (e.g. ASV and ABPAP).

There are many aspects of the paper that also relate to OSA/UARS patients in general and not just PTSD patients. As we delve into it, keep in mind the material may be relevant to many mental health patients using PAP therapy as well as those with more classic presentations of sleep apnea. The most difficult aspect in organizing a retrospective chart review of this type (which was the research design for this study) is the need to avoid cherry picking the data that might make something appear more effective than it really is. Moreover, since our study was not with a sophisticated control group, the results only represent what are called “associations,” which is a lower level of evidence in research. Just because lots of people do well with ABPAP or ASV doesn’t necessarily clarify whether ASV or ABPAP are superior modes of treatment when they were not matched against CPAP devices.

One factor in the research, however, that provides a highly relevant degree of credibility to the work is that every patient in the study had tried CPAP in some way, but failed it, found it intolerable, or outright rejected it. Such patients then are said to serve as “historical controls,” because they tried one treatment in the past that clearly did not work for them and then tried a different mode (ASV, ABPAP) that did work. Of course, you can see if you don’t know all the circumstances surrounding their failure with CPAP, then we can’t be certain the comparisons are valid. For example, suppose before visiting our center, all the patients had attempted CPAP at a sleep center that provided very little support for its patients. Or, suppose the CPAP settings were frequently too low or too high, because the sleep laboratory they used did not take the time to fine-tune their pressure/pressures if the patient had been prescribed an Auto-CPAP (APAP) device, an increasingly common practice. In other words, there are so many variables that could alter our perspective about the nature of CPAP failure, we just cannot know reliably if we should assume CPAP could never work in these individuals.

Another major concern about the flow of patients in this sample is the problem of inherent chart reviews where individuals will have missing data or drop out along the way. Which means how could you declare that your findings are fully representative of the points you are trying to establish? In fact, you cannot, and you must report this problem as a major limitation of the study. Let’s look at our published flow chart to understand the problem:

We start out with 229 PTSD patients who marked their PTSD as moderate or worse and who had been tested and shown to suffer from OSA or UARS. The PTSD scale was a well-known, validated survey known as the PSS-SR published by Foa and colleagues a few decades back. Nonetheless, we did not conduct specific PTSD interviews with the patients to confirm the diagnosis. Instead, we selected the higher severity level (moderate or greater) as a more likely indication PTSD was probably a valid diagnosis from the patient’s perspective.

Next, to examine whether or not these patients would do well with a certain type of PAP therapy, they would also need to undergo a titration study and of course be prescribed a PAP device to use at home. This step brings us to a major design flaw in our work. Because 47 people refused to return for a titration study despite receiving clear information of their diagnosed sleep disordered breathing, and another 35 patients who despite undergoing a titration never filled a prescription to attempt PAP at home. You see that we are already down to a new subtotal in our chart review of 147 who completed the additional steps noted above. But that means we had nothing to look at in 82 (47 + 35) patients or nearly one-third of our original sample.

At this point, we don’t throw in the towel because we know that in medical research in particular, it remains a worthy exercise to make observations and analyze data on active treatment-seeking patients. Although we recognize our data would be more generalizable if all 229 patients had followed through, and in reality patients drop out of care all the time and for numerous reasons. They may even still be treatment-seeking for their sleep problems, but they simply were unwilling or unable to proceed with the PAP approach to treatment.

Of the remaining 147 patients who attempted PAP, some early good news was that only 17 patients provided no further data, because 8 got the device but let us know they stopped using it. Another 9 were lost to follow-up, so we have no info on them. That leaves us with 130 patients who were diagnosed with sleep-disordered breathing, filled a prescription for PAP therapy. All these patients appeared to be making some reasonable effort to use the device at home. There were four criteria we applied to make this observation, any one of which was sufficient to declare the patients a current user:

  • They had recently received a prescription to renew PAP supplies
  • They had a recent clinic appointment where they confirmed they were using PAP
  • They returned to the sleep lab for retitrations and confirmed they were using PAP
  • They had been in contact with the sleep center staff and confirmed their use

With these categorizations, we would have hoped to provide insights on the 130 PAP users, but here again we have the dilemma of capturing downloads off their machines either through our efforts at the sleep center or from data provided by their DME company. In fact, 28 patients had no such data available in their charts, and even after we searched other resources such as contacting their DME company, we were left with a final sample of 102 PTSD patients who met all criteria. This included the essential data acquired from the machine. Now, you see that we are down to a sample that remains sizable and is considered large as it involves 100 patients or more, but it is less than half of the original working group. Again, these adjustments may bias the research because we do not know what the outcomes were for the other folks in the original sample who did not meet all the requirements. As you can see, these are the major weaknesses of a chart review.

Forging ahead, we can still learn a lot from the 102 PTSD patients, but we must respect the fact that these individuals may be more highly motivated to pursue PAP than others who dropped out of care. Thus, when we come to the point of making our observations about their use of advanced PAP devices, we need to be realistic about how our approach may apply only to PTSD patients who are not only treatment-seeking but perhaps with a higher level of motivation than other PTSD patients.

And this flow of patients now brings us to the main data point of the study, which was 59 of these patients (or 58% of the working sample) were not only using the device, but using at a high level. They were all compliant or adherent, using nearly 7 hours per night on 94% of possible nights. Another 19 patients were called “sub-threshold” compliant because they did not meet the insurance standard of 4 hours per night for 5 nights/week or about 20 hours per week. Nonetheless, many of them were nearly compliant because they average more than 25 hours per week.  However, since they might have lower hours on some nights or not used on some nights, they did not meet the insurance convention.

This concept of sub-threshold compliance was a major reason we wanted to conduct the chart review, because we knew that many PTSD patients require a longer interval of time to adapt to a device, even if the device should be an advanced one (more on this idea later). The last group used minimally, averaging a few hours for a couple nights per week. However, as we described later in the discussion section of the paper, the question must be asked, what would make a minimal user become a sub-threshold user, and what would make a sub-threshold user become a compliant user? Clinically, these questions are extremely important to answer, because they directly address some of the difficulties so many sleep centers experience in trying to help patients use their PAP machines.

Just how difficult are these patients to treat? The concept of “difficult to treat” is really hard to define. But we can at least describe some aspects of our sample so you get the big picture. All these patients suffered something approaching severe insomnia. On average, they took more than an hour and a half to fall asleep at bedtime. Once asleep, they would later spend more than two hours awake in bed. The insomnia issues alone are very problematic, since several studies have described how insomnia often interferes with efforts to use PAP therapy.

In addition to the PTSD problem in all the patients, 76% of them suffered from one or more additional anxiety disorders (generalized anxiety, panic attacks, obsessive compulsive disorder), and 82% suffered from one or more depressive disorders (depression or manic-depression). Most of the patients suffered moderately severe sleep apnea with an average AHI of 26 and an RDI of 57.  With this information, we know the difference between these two metrics that our patients (on average) suffered many RERAs. The exact mean was 31 events per hour, so many patients suffered from more RERAs than apneas and hypopneas. And, patients with more RERAs may prove more difficult to treat, because when trying to eliminate the RERAs with higher pressures, expiratory pressure intolerance (EPI) is often triggered.

Indeed, this finding of the high RERA index explains in part the finding that 64 of the 102 patients developed the problem of complex sleep apnea, the condition where central apneas emerge as a side-effect to the use of pressurized air. The other 38 patients were on auto-bilevel (ABPAP).

Now that you know some of the major findings in the research, let’s back up to the beginning of the story to see why we elected to conduct this chart review in the first place. Then, we’ll spring forward again to further elaborate on key clinical points in our patients experiences with advanced PAP. Finally, we’ll end with our discussion section where we talk about how patients and sleep professionals might make use of this research and what new research is needed in this area.

The beginning of the story is not exactly what you might expect. Of course, we delved into how difficult it seems to be for PTSD patients to use CPAP therapy. And, we report on one of the most recent studies from the Walter Reed group in Maryland that shows low rates of compliance—around 30%. But, we also cited a much more interesting and motivating reason to explore PAP in PTSD patients – which is the early findings that treatment of OSA/UARS might actually be associated with a decrease in post traumatic stress symptoms. We cited two studies, the work of Youakim and colleagues in 1998 (1) and our own study in 2000 (2). Although we did not go into the details of these two works, it is worth mentioning here that both of them reported on small samples of PTSD patients who appeared to improve their symptoms by using PAP therapy.

The clinical relevance of our paper could not have been timelier, as several other researchers have published on the same or similar ideas in just the past two years. Just inserting the words PTSD and CPAP into a PubMed search will bring a list of 10 recent papers during 2016 and 2017, covering either the difficulties in PTSD patients using PAP therapy or the effects of PAP therapy on relevant PTSD symptoms. A search of “PTSD and OSA” brings up additional relevant articles. This new input is a radical change from the past where the comorbidity of these two disorders was virtually ignored, except by a very small number of research groups. Now, the advances are coming so fast that there have even been articles looking at the relationships between OSA and their impact on PTSD patients responding to specific PTSD treatments. For example, exposure therapy or cognitive processing technique, which are two of the most advanced and consistently validated therapies for trauma survivors.

We could not be more delighted to see this sudden change in interest. In fact, we co-authored a commentary on this topic, (3) pointing out the fallacy in one study that had attempted to argue that sleep disorders assessments did not required prior proceeding with the treatment of PTSD. (4) In our commentary, we cited the excellent work of my co-authors who demonstrated how the presence of untreated OSA seemed to be associated with lower therapeutic effects in PTSD patients attempting exposure therapy. (5)

In our lengthy introduction in the paper, we also describe two specific areas of interest that relate to the general population of OSA patients, as well as to psychiatric patients including PTSD cases. The first concept is that of “sub-threshold compliance,” a woefully under-researched area in PAP studies. Sub-threshold compliance is also termed “partial use.” Though research has previously shown that using PAP just 2 or 3 hours per night (and in some cases even fewer hours) leads to clear-cut clinical benefits. We often find no support for this clinical pearl in the general sleep medicine community or in dealing with insurers who seem to be caught up in the decidedly non-clinical construct of adherence. Specifically, the Medicare criteria for compliance is 4 hours per night on 70% of nights. This amount of use translates into 4 hours x 4.9 nights per week or rounded up to 4 x 5, which is 20 hours in the week. Yet, no insurance carrier (to our knowledge) will sign off on a patient using PAP 20 hours per week unless the 20 was achieved through the arbitrary and to repeat decidedly non-clinical construct of 4 hours on 4.9 nights/week over a one month period. We’ll delver further into this idea later in the post.

The second key concept is how our approach is different than most others in managing the problem of PAP compliance. Most centers use behavioral change models, psychoeducation, or other coaching techniques. Although our sleep center in New Mexico uses some of these tools as well, our primary focus targets the patients “experiential and emotional reactions to pressurized air.” Summing up the approach in the paper:

“…psychiatric patients exposed to CPAP are susceptible to the problems of anxiety sensitivity and somatosensory amplification. In our clinical experience, both of these transdiagnostic vulnerabilities are triggered when attempting to use fixed pressurized air. As CPAP delivers the same pressure setting on inspiration and expiration for any given breath, the patient is always exhaling against a pressure greater than required to maintain a patent airway, an objectively proven observation described in the sleep literature since 1990. This fixed pressure on exhalation often produces an uncomfortable sensation sufficient to trigger PAP intolerance, and in vulnerable patients, claustrophobic or panic reactions flare up. Thus, at our sleep medical center, which specializes in the treatment of psychiatric patients with sleep disorders, we observe CPAP technology itself as a major cause of low adherence or outright rejection.”

The way some people might experience headaches provides the most practical way to explain these concepts. Some people develop a headache, come up with an effective plan to treat it, and then continue on with their daily activities. Other people experience a headache, and some part of their personality makes them continually reflect back on or monitor what’s happening with the headache. This extra attention given to the headache is called attention amplification or attention bias. Bottom line is that when you pay too much attention to the headache, the problem not only fails to resolve, it often worsens in intensity. The nearly identical process occurs with unpleasant sensations from CPAP. The patient is unable to stop thinking about the mask on her face or the pressurized air being delivered, which makes either of these sensations more uncomfortable than originally experienced. Eventually, the patient notices these sensations so much that falling asleep becomes impossible.

One might think that teaching a patient to distract the mind to pay attention to something else would solve the problem. In fact, we use an imagery distraction technique. Which is self-guided daydreaming in the mind’s eye, to help people stop thinking about the mask and the pressure. Yet, despite great success with this approach in many patients, it does not bring the patient all the way into a place of comfort to be able to tolerate the fixed pressures of CPAP. This is because imagery distraction cannot always resolve the problem of expiratory pressure intolerance. Instead, by switching patients to bilevel, auto-bilevel (ABPAP) or ASV devices, we find the patients can gain comfort when breathing out against the lower pressurized air. This change in technology is what helps them to avoid paying too much attention to the “unnatural” flow of air into the nose and throat.

These approaches appear to us to be the most relevant ways in which we can help someone overcome their adaptation difficulties with CPAP. First, teach them how to distract themselves from the sensations of CPAP so that the experience is not emotionally overwhelming. Second, provide the patient with advance technology, which in and of itself leads to greater comfort and therefore acceptability from the patients’ perspective.

In the next post we’ll delve deeper into other fine points of the results from the research and finish up with our discussion points on how to use the information in clinic and what research is needed in the future.

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References

  1. Youakim JM1, Doghramji K, Schutte SL. Posttraumatic stress disorder and obstructive sleep apnea syndrome. 1998 Mar-Apr;39(2):168-71.
  2. Krakow B, Lowry C, Germain A, Gaddy L, Hollifield M, Koss M, Tandberg D, Johnston L, Melendrez D. A retrospective study on improvements in nightmares and post-traumatic stress disorder following treatment for co-morbid sleep-disordered breathing. J Psychosom Res. 2000 Nov;49(5):291-8.
  3. Reist C, Gory A, Hollifield M, Krakow B. Potential benefit of sleep assessment prior to PTSD treatment. Psychiatry Res. 2017 Aug 30.
  4. Sexton MB, Avallone KM, Smith ER, Porter KE, Ashrafioun L, Todd Arnedt J, Rauch SAM. Sleep disturbances as predictors of prolonged exposure therapy effectiveness among veterans with PTSD. Psychiatry Res. 2017 Oct;256:118-123. doi: 10.1016/j.psychres.2017.06.044. Epub 2017 Jun 14.
  5. Reist C, Gory A, Hollifield M. sleep-disordered breathing impact on efficacy of prolonged exposure therapy for posttraumatic stress disorder. J Trauma Stress. 2017 Apr;30(2):186-189. doi: 10.1002/jts.22168. Epub 2017 Mar 8.