Nasal Dilator Strips Update 2019: Part II

With such an array of opportunities to use NDS therapy and other conservative treatment approaches, one of the most important research areas for study would address how non-sleep, medical professionals recommend these steps to their patients. Regardless of how things shake out in sleep centers, more health professionals and especially primary care physicians, psychiatrists, and psychologists (not to mention assorted mental health therapists) are going to be asking virtually all their patients, “How are you sleeping?”

Primary care physicians are probably the most pivotal group to study, because they experience directly or indirectly so much of the frustrations patients report in attempting PAP therapy. The complaints may consist of the specific difficulties in trying to use or adapt to PAP as well as complaints about dealing with sleep center or DME personnel, not to mention the ever present struggles with insurers that so often plague PAP patients.

Imagine a study that examined NDS therapy in the context of a very large primary care practice facility, the type that houses ten or twenty or more internists and family medicine physicians. These large groups are increasingly common due to mergers among many medical businesses as well as the tendencies for large hospitals to expand services to grow even larger.

In this main arena of healthcare, as awareness increases regarding the vast number of sleep complaints among their caseloads, eventually an executive or medical director of such a facility would recognize the epidemic in their midst comprising presumptive cases of sleep-disordered breathing, despite so many patients visiting their facility for just about everything else but sleep issues. With a very succinct questionnaire of ten items or less, a triage system could easily identify patients with presumptive SDB. How then would these physicians proceed to engage their SDB patients in orderly fashion to take steps towards diagnosis and treatment? Would they all be referred to a sleep center? If so, how long would it take for the patient to be tested? What kind of testing would be available? Who would be running the DME program? 

If the answers don’t immediately come to mind, consider what is happening right now in primary care. When a patient mentions a sleep complaint, the more immediate evaluation might be towards insomnia and the need for sleeping pills, over the counter or prescription. However, there are newer trends indicating physicians are increasing their frequency of questions about snoring, witnessed apneas or other problems with sleep quality. If a primary care patient reports problems with sleepiness or fatigue or medical co-morbidities, like high blood pressure or arrhythmias, there may be even greater attention given to underlying sleep issues as more and more physicians focus in on these connections.

The bottom line is that sleep disorders will eventually fall into the same paradigm as seen with other chronic conditions. Originally, psychiatrists treated depression, or endocrinologists treated diabetes. Over time, and especially as it related to medical management (i.e. medications), more primary care physicians (for better or worse) acquired the training, experience or habit of treating patients with depression or diabetes and no longer relied on the specialists. They learned enough information to prescribe medications, and the best among them kept current on trends and evidence in the field to guide their adjustments to these medications. 

This same pattern for sleep disorders is going to evolve in the primary care setting sooner than later, because of the overwhelming number of OSA/UARS cases to be treated coupled with the inadequate number and distribution of sleep specialists. In other words, it is this area of clinical care that will soon be the most ripe for research investigation of conservative treatment steps, because all these patients will not make it to a sleep center or certainly not in a timely manner.

Bear in mind, however, that entrenched thinking about NDS therapy in many areas of medicine in general, and even in sleep medicine in particular, either ignores the potential value of this treatment strategy or denies its efficacy. This constrained view actually creates a much greater potential for game-changing research, because an investigation among primary care patients successfully using NDS therapy could bring us to a very desirable tipping point. And, what’s even more interesting about this potential change in thinking is it would lead primary care physicians and other primary care providers to increase their awareness about sleep issues to the point of raising more questions and making more referrals. To be clear, this process is not one of “if you build it, they will come.” Rather, knowledge that something works or has a reasonable degree of probability for working will inspire providers to gain more awareness of sleep issues, because they would possess a simple recommendation to offer to their patients.

As an aside, I recently conducted a two-day workshop for a group of mental health providers in Chicago, who invited me to teach them how to manage sleep disorders in their practices. As I have mentioned previously, mental health providers have a very different slant on sleep disorders than most other areas of healthcare, because virtually every day they are seeing a lot of patients with sleep complaints, because sleep symptoms are a major component of mental illness. As often happens near the end of the workshop, we must discuss how the mental health practice must interact with local sleep centers, and typically the discussion leads to concerns about barriers arising. The largest barriers are that so many sleep centers do not recognize the high prevalence of OSA/UARS in mental health patients and instead write off their sleep complaints to psychiatric disorders. Indeed, even if a patient from a mental health facility is sent for sleep testing, it is not uncommon for the diagnosis to come back with the following words: “mild sleep apnea and the patient should avoid sleeping on her back.” In other words, they often miss the UARS component of the condition, or they simply believe that since the OSA diagnosis is merely mild, then the patient’s mental problems must be the real culprit needing the most attention.

At this point in my workshops, I spend a great deal of time explaining the rationale for conservative sleep breathing treatment strategies, all focused around nasal hygiene. In my discussion of NDS, I explain how to use the nasal strips, how to place them correctly on the nose, and how to remove them to avoid any skin irritation. In this discussion, you can figuratively see the light bulbs forming above each attendee’s head, because they realize they’ve just been handed a tool to use directly in their practice without having to wait for everything to be managed by a sleep center. I will return to the mental health arena as another area for research, but I want to pick up on the rest of the topic of primary care.

A related example in primary care is how physicians currently view the role of melatonin. The growth of melatonin did not start with the medical world, so to speak. Instead, it was pioneered by the alternative medicine community, where the role of vitamins, mineral, supplements and other so-called natural remedies are promoted with great vigor. Melatonin was advertised all over the map as a natural supplement for insomnia, and because melatonin is a known hormone naturally produced in the body at night during the sleep period, it seemed logical people would buy into the idea of it working as a sleep aid. Yet, the research in terms of well conducted studies only showed a likely need for melatonin among elderly people with melatonin deficiencies or for those with jet lag issues. This limited evidence did not impede the suppliers from advancing their marketing into the global population of those suffering from either insomnia or poor sleep quality, a quite sizeable number of people.

As a result of this push from the manufacturers of melatonin, physicians began to see and learn about the supplement because their patients were self-selecting it to treat insomnia or poor sleep quality.  This phase of development went on for years until finally enough doctors heard such positive results from their patients; the physicians themselves started recommending melatonin. Next up, more research or more manufacturing innovations have led to increasingly sophisticated melatonin concoctions. And, in just the past year, a new extended release melatonin has come on the market, following a very well-conducted, placebo controlled randomized controlled trial to prove its benefits. This product is likely to spawn more melatonin supplement research, more products and more growth in the sale of melatonin products. 

The above example of patient-driven use of a product is already what we see in the marketplace for NDS therapy. The promotion of nasal strips has not been as aggressive as that conducted for melatonin, but the pathways are still similar. Patients are driving the sales of NDS, much more so than doctors are recommending NDS, even though there is sufficient evidence for physicians to already be considering such recommendations.

For these reasons, locating one large primary care practice and working with that group to teach them about conservative treatment steps, including nasal hygiene in general and nasal strips in particular would be the ideal scenario to research from the standpoint of wanting to see more patients start their OSA/UARS treatment sooner than later. By the way, virtually everything discussed so far and going forward also applies to the DME environment, because so many sleep centers do not rigorously work on nasal hygiene programs for their patients. Thus, conducting research at a DME would permit application of NDS therapy on one group of new PAP users, which would be compared to another group not offered NDS therapy. 

A research project of this type ultimately requires certain premises to bring into play all the necessary variables to yield comprehensive results. The most difficult premise to deal with is whether or not a patient suffers from sleep-disordered breathing even if the condition turns out to be mild. (Of course, the premise is easily solved in a DME environment where patients have already been diagnosed and prescribed PAP). In seeking to create a context where primary care physicians would accept and eventually embrace the outcome of the study, patients would require the diagnosis of a sleep breathing disorder on HST, which would be the most expedient way to recruit the right patients. However, the HST must be of the type such as the WatchPAT to account for UARS.

The next premise would to identify the right outcomes for measurement pre and post NDS therapy. From past research, we already know NDS therapy will improve quality of sleep and quality of life measures as well as decreasing insomnia severity and impairment related to fatigue and sleepiness. Four scientifically validated measuring tools were used to determine the efficacy of NDS therapy in our 2004 original randomized controlled trial. And, by the way, these changes were not on a small scale. All improvements met statistical significance criteria for medium to large effects. As the best example, insomnia severity in the NDS group from a starting point designated as moderate severity ended up decreasing to below the actual cut-off for clinically relevant insomnia, that is, scores dropped from 15 to 10 on average, which represents a huge change for the better in the insomnia condition. Even among secondary variables, such as nocturia, morning headaches, and dry mouth upon awakenings, the findings showed consistently more benefit in the NDS therapy group compared to controls, although for these variables the sample appeared too small to achieve statistical significance. One of the most remarkable aspects of the research was how the patients treated with NDS therapy consistently reported across the board subjective improvements in breathing symptoms, in various sleep quality symptoms, and in various insomnia components.

Thus, there would be a host of variables from which to choose in a research investigation to prove that patients were gaining better sleep and related outcomes with the sole use of NDS therapy for their recently diagnosed OSA/UARS. To make the research as feasible and expedient as possible, we would expect to use the least complicated measures and the fewest in number.

Another premise is whether or not to design a research protocol with exclusions. For example, would you want someone with chronic pain using opiate medications to enroll in the study or would you be worried both the pain and the opiates might make it difficult for the patient to discern any changes in their sleep? What about someone on multiple psychotropic medications for multiple psychiatric conditions? Many of these drugs numb patients during waking hours and also affect sleep in various ways. Would these individuals prove to be reliable research participants? Or, what about a patient who suffered a propensity for skin irritations, for example easily sunburned or very dry skin? Would these people be able to tolerate the adhesive of a nasal strip? Most research looks to clarify the most important or clinically relevant exclusions, but in general the more exclusions yields final results that are less meaningful or generalizable to the community at large.

A final premise to consider is the duration of the study. The longer the protocol runs, the more meaningful the data. Our RCT for nasal strips only ran 4 weeks, yet the results were fantastic after just this short period. We even recognized that lots of patients had done well after two weeks of use. Still, after the controlled study was completed, we continued to monitor the majority of patients who agreed to wear the nasal strips for another 8 weeks, and in the new extended window several patients who had reported no prior improvements in that first month now reported clear-cut benefits with longer use. Anecdotally, there were a small number of patients who still could not detect any differences from using NDS until they stopped using the strips for a few days or a week. Then, it crystallized in their minds how much better sleep was as soon as they began wearing NDS again or the reverse, that is, they realized how bad sleep was without the nasal strips.

When such studies or the many variations of protocols are completed, we would expect to come close to overcoming the tipping point for the awareness of the high prevalence of sleep breathing symptoms and disorders in primary care clinics. Moreover, we would further expect to see a notable change in perspective where providers think more urgently about starting treatment of these problems at the primary care level instead of waiting to treat OSA/UARS at the sleep center level.

As described above, mental health is also a large arena in which to conduct NDS treatment research. Arguably, mental health is the largest domain to consider for advancing the use of conservative treatment steps for OSA/UARS, because the epidemic of sleep-disordered breathing in this milieu is astronomical, even larger than what’s seen in primary care. However, the problem going forward is the huge gap of awareness between what mental health patients are complaining about and how their doctors and therapists are interpreting these symptoms. As the best example, we’ve done numerous studies on the sleep in PTSD patients for whom I must point out the PTSD diagnosis almost always includes reports of two sleep disorders: nightmares and insomnia. Indeed, our earliest work in research was to treat the nightmares of chronic PTSD patients, where we applied a cognitive-imagery technique known as Imagery Rehearsal Therapy with great success. In the course of that study that lasted more than six years from inception to publication in the scientific literature, we became increasingly curious about what appeared to be the much greater complexity to the sleep disorders in these research participants, all of whom were young to middle-aged female sexual assault survivors. 

The findings that repeatedly emerged in other studies and which were subsequently published in 16 different peer-reviewed articles in psychology, psychiatry, sleep, or respiratory journals unequivocally demonstrated a high frequency of OSA/UARS in trauma survivors. As you might imagine though the idea of a trauma survivor attempting to use a PAP mask is often a nonstarter. And, although we have had considerable success in using advanced PAP devices in this population, this group of patients would on the whole be far more receptive to conservative treatment steps.

Another gap arising in mental health research is to persuade the mental health providers that the sleep complaints they are hearing about from their patients are in fact masking their underlying sleep breathing conditions, that is, if someone is talking about nightmares or insomnia, why would you suspect OSA/UARS? And, to reiterate, if the mental health provider enlists the aid of a sleep center or sleep specialist, they will not infrequently be ridiculed or simply dismissed for sending a “psych” patient for an evaluation of a medical disorder. 

With this backdrop, conservative treatment steps involving nasal hygiene in general and NDS therapy in particular is an ideal match for mental health system patients. One of the best aspects of a research protocol in this arena involves the high frequency of regular patient visits into the system. Many mental health patients visit providers weekly or bimonthly or monthly, which means a protocol could easily be introduced into the regular workings of their systems. Not only would follow-up be easier, but treatment adherence would probably exceed 90% due to the regular contact with a psychiatrist, psychologist or therapist. And, management of side-effects would be much easier, because patients would be reporting complaints in a timeframe where they would likely be seen again just a few days later.

Ultimately, conservative treatment steps for mental health patients may prove to be the only way forward, given how much resistance already exists among sleep professionals to seriously consider their sleep complaints coupled with some of the trends described earlier in which contraction of sleep center services appears to be on the horizon. NDS therapy then could easily function as a bridge treatment between primary providers and sleep centers, albeit many of these patients will continue to show reluctance for more advanced treatments, such as PAP devices or dental devices, due to high levels of claustrophobia in this population. 

Finally, a whole other area of research involves various types of limited or non-treatment seeking individuals. A very common type would be the individuals with sleep complaints who don’t talk to their doctors but do visit drugstores for relief. Another subgroup here would be those with sleep complaints who talk with no one, and they do not seek relief at drugstores, even when their problems are as apparent as chronic nasal congestion. Yet, another group has no sleep complaints or any nasal issues, but they are the type seeking an “edge.” They may want to run faster or improve their endurance. Or, they want to walk faster or swim easier. Thus, they might start by using a nasal strip for daytime performance, and through the passage of time, they may wonder whether NDS would have some impact on their sleep. These groups tend to fall outside the domains of traditional medical or healthcare services, but they are interesting in that they reflect an area of patient-driven forces that promote the use of OTC medications or devices and thus play a major role in how products emerge and expand within the marketplace.


Barry Krakow MD

Author

Dr Krakow’s 27 years of sleep research have focused on the complex relationship between physiological and psychological sleep disorders. Dr Krakow currently operates private sleep medical center, Maimonides Sleep Arts & Sciences, Ltd., and serves as Classic SleepCare’s paid Medical Director.



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