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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.