Nasal Dilator Strip Update 2019: Part I

In 2015, we last discussed nasal strips (NDS) in depth to point out their wide applicability. With increasing experience, I would like to update a few aspects of this conservative yet effective treatment strategy, because I see certain trends indicating a larger growth potential than previously forecast.

As briefly mentioned in a recent post, a close relative of mine used a nasal strip one night and was stunned by the dramatic improvement in sleep quality noted on his Fit-Bit. He was also intrigued by the notably enhanced sleep quality he experienced that night and was unequivocal about sleep being more refreshing and daytime energy levels being higher. However, this individual was not a treatment-seeking sleep disorder patient. Rather, his experimentation with NDS derived from a chance conversation at a family outing. Eventually, despite these apparent gains, the individual experienced no concomitant motivation to maintain regular use of NDS, though it is used occasionally.

A second related case involves an individual I met on a recent trip, and with more time for a more involved conversation, we discussed three chronic health problems including hypertension, nocturia, and cardiac valve disease. This scenario was diametrically opposite than that of my relative, because this gentleman has been under the care of multiple doctors, yet none of them have mentioned the imperative to undergo overnight sleep testing, whether by home sleep testing (HST) or polysomnography (PSG), despite the presence of these three conditions, well-known for their inter-relationships with OSA. When we discussed these connections, he was eager to learn more for no other reason than the age old wisdom that “suffering is the greatest motivator” to seek solutions to health symptoms. Though he anticipated having difficulty with using a CPAP device, he was intrigued by the notion of NDS actually providing benefit and literally left our meeting to head directly to a local pharmacy. The next morning he too marveled at the immediate improvement in nasal breathing. Of additional clinical import, his wife declared he had not slept so peacefully and soundly in years. In his case, NDS will be used for as long as it takes to complete formal sleep testing and might be used thereafter in conjunction with PAP therapy.

These two cases manifest the polar extremes of NDS use. In the first case, we have a non-treatment seeking individual who happens to gain new knowledge about nasal strips and elects to try it a few times. Despite marked improvement, there is no motivation to keep using it. In the second case, serious medical disorders and symptoms are in play, and the individual is eager to attempt any treatment immediately to gain even the slightest improvement.

From a marketing standpoint, it should be apparent that the latter case describes people who could walk into a local drugstore to explore various nasal strips for sale. In the former case, the individual would walk right past the nasal strip section, arguably because he or she would have never heard of the product or its applications.

Based on trends I am observing in the field of sleep medicine, I believe this marketing issue could change in ways that will more readily see patients incorporating NDS into their sleep care, because of two paradoxical influences. One, we are witnessing increasing awareness of the OSA/UARS epidemic in our country and elsewhere, but two, this awareness is now coupled with a corresponding contraction of sorts in sleep medicine services. If the contraction in sleep medicine services worsens, it will perforce lead to more and more individuals searching for conservative treatment options such as NDS.

The first component of this equation—increasing awareness of OSA/UARS epidemic—is a no-brainer, because so many different fields of medicine are now referring patients to sleep clinics and labs. Some of the more obvious growth is in the field of cardiology and cardiovascular disease, where cardiologists are now embracing the viewpoint that nearly all their atrial fibrillation cases as well as congestive heart failure patients must undergo sleep testing, due to the aggravating effects of OSA. Some cardiologists refer patients for additional cardiac arrhythmias or for coronary artery disease.   And, despite the fact there is increasing scientific evidence for referring cardiac cases, this new influx of heart patients into the sleep medicine environment is actually driven much more by doctors witnessing changes in other patients who after having used PAP therapy witnessed an elimination in symptoms or a decreased severity of symptoms, specifically eradication of arrhythmias or easier management of congestive heart failure with PAP therapy.

In psychiatry, I am literally reviewing a paper this week for a leading scientific journal on the topic of whether or not treatment resistant depression should mandate the use of sleep testing to determine if an OSA diagnosis might be the culprit for the lack of effectiveness of the antidepressants. More research is coming out in mental health on the connections between OSA and PTSD, such that you now see this co-morbidity mentioned even in what I call the same-stream media, that is, the place where once an idea takes hold it gets repeated as “news” virtually everywhere from newspaper, magazines, blogs and so on, which eventually turns it into the new conventional wisdom. Sometimes, this process is quite valuable to society, while more frequently than recognized the process turns elevates certain myths into entrenched dogma (i.e. conventional wisdom), such as described below regarding the so-called optimal number of hours of sleep conundrum.

The list of interconnections and enhanced outcomes goes on in other realms as well, such that now we see that many current OSA patients and their assorted doctors are spreading the word that sleep breathing disorders are a big deal. I am not declaring this trend as the ultimate tipping point, because there is still quite a ways to go, but I am persuaded the recent changes reflect another very large step forward in this inevitable process where eventually nearly all relevant patients will be referred for sleep medicine services by their primary care physicians or by the patients themselves.

The matter of contraction of sleep services, on the other hand, is more complicated and not so easily discernible. The main factors involved are no different than what has been described previously in many places as well as on this blog site:

  • Sleep testing services are allegedly expensive
  • Home sleep testing should supplant in-lab sleep testing
  • PAP has poor rates of adherence
  • Alternative treatments to PAP must be developed.
  • The shortage of sleep medicine physicians may never be resolved
  • The sheer number of eventually diagnosed cases of OSA/UARS demands other pathways to treat the condition.

An entire blog post could be written about each of these factors. Here, we will attempt to integrate aspects of these issues to form a cohesive argument to explain how the contraction of sleep medicine services actually favors the advancement of conservative treatment options. In going through this list keep in mind how each step creates more limitations on patient care and thus leads to more patient frustrations, all which leads to individuals searching for add-on treatments to solve problems.

Whether or not sleep lab testing (PSG) is expensive and whether HST can supplant PSG are both essentially moot, because the “handwriting is on the wall.” In other words, the perception that sleep studies are expensive and that only HST can save the day is now taking root in medical circles and will soon become deeply entrenched as the new conventional wisdom among insurers as well as government regulators and primary care physicians. It does not matter how much lower the quality of care falls via HST, as it most assuredly will be in the short-term, because the verdict is already in that the HST/APAP model of care is not only comparable to the sleep lab approach, but also, adherence rates with HST/APAP are just as good as the lab approach. And, because adherence (de facto hours of sleep per night), not quality of sleep, is the benchmark through which sleep medicine services are judged for OSA/UARS therapies, quality of care must decline as it always will when sleep professionals focus too much on how many hours of sleep someone is gaining instead of focusing on the quality of the individual’s sleep. 

Once society succumbs to the fallacy that hours of sleep are more important than sleep quality (a fallacy deeply entrenched in societal viewpoints about sleep), then it becomes apparent that no matter how you teach someone to gain adherence status (i.e. 4 hours per night for 5 nights/week), all subsequent emphasis will disregard a patient’s persisting sleep complaints, because the ultimate goal has been achieved—the so-called necessary number of hours of sleep. If you do not believe this statement, consider the following: there are sleep physicians and insurers all across the USA and elsewhere who literally believe their jobs are done once their patients become adherent. As a reminder, you know how often I talk about the connection between sleep apnea and nocturia and how we preach that at least 50% of PAP users should eliminate all trips to the bathroom. Moreover, we profess that this percentage is most likely an underestimation of the true potential to eradicate nocturia with PAP therapy. Nearly all evidence points to such outcomes, yet most insurers and even lots of sleep professionals remain convinced to simply ignore or lose sight of the nocturia connection, despite this highly problematic symptom continuing to affect so many successfully adherent PAP cases.

Adherence or the number of hours turn the sleep medical system upside down and degrade the quality of care in a large majority of cases. Eventually, these patients are going to become frustrated if not angry for the inadequate if not mediocre care they are receiving. Many may take a long time to sort out these deficiencies, because it is so hard for people to determine what a higher quality of sleep represents over either the short or the long-term. But, sooner or later, they will hear about the failure of their sleep professionals to direct them in new or different ways to solve problems previously believed to be unsolvable, like nocturia. I have met thousands of patients treated by board-certified sleep doctors, who never informed these patients their nocturia might disappear once they attained an optimal response to PAP. Instead, they simply repeated the empty mantra: 4 hours of sleep for 5 nights per week. In the meantime, their patients suffer the consequences of inadequately treated sleep-disordered breathing.

In due course, people learn enough from other people or other information resources that will lift the veil on the poor services they are receiving. And as these insights are experienced by increasing numbers of patients with poorly treated OSA/UARS, they will demand alternative treatments. One of the up and coming approaches is the Inspire technology that implants a neurstimulation device into the body in ways similar to a pacemaker and which creates a pacemaker-like system that stimulates the nerves to the base of the tongue. This device causes the tongue to retain greater rigidity while sleeping and thus decreases the apnea-hypopnea index. There is an even a titration component to the Inspire system, theoretically making it plausible to incrementally increase the capacity of the device to decrease UARS breathing events, aka flow limitations or RERAs (respiratory effort-related arousals).

Furthermore, all during the advent of the field of sleep medicine, many patients underwent surgical procedures to treat the condition, and surgical options are also going to see more precision and efficacy in the coming years. The same is true with OAT, where increasingly sophisticated dental devices will improve the quality of sleep.

If you summarize the above information in terms of services, it sounds like there is a broadening of options for patients. However, few of these options except PAP actually lead to superior or near optimal to optimal results. Instead, these options all provide some degree of efficacy, but most cannot compete or attain a state of equivalence case by case with PAP. Thus, the contraction we are describing here refers specifically to sleep center services, involving the use of the sleep laboratory environment to initiate and optimize the application of the gold standard therapeutic option of PAP therapy. These services are on the decline, because sleep centers are under attack for using in-lab tests that are allegedly too costly, because HST can replace PSG allegedly without a decline in care, and because patients allegedly don’t use PAP much anyway so why bother with all the expensive care when it goes to waste. To be clear, there are many sleep centers still functioning at high operational lab levels. But, as these anti-lab viewpoints become entrenched, more and more doctors especially PCPs who often hear the horror stories of patients suffering through the adaptation problems of PAP will start referring more of their patients to surgeons and dentists or anyone else who can offer alternate remedies.

In some ways, this emerging phase in the field of sleep medicine could lead to healthy competition, wherein sleep centers and DMEs learn to work more closely together to provide faster and more efficient adaptation approaches, so that patients enjoy the benefits a lot sooner while suffering thru the PAP hassle factors a lot less. Doing so would likely shift patient loads back toward PAP, but it remains to be seen how well sleep centers and DMEs can coordinate efforts, and it remains to be seen whether either or both institutions will raise the banner to focus on better sleep quality, which 99% of the time is the only way to point a patient toward optimal results.

More probably, over time, as sleep services decline in the main clinical fields of sleep medicine, we would expect services to increase in fields of surgery or dentistry, leading to new standards on what constitutes gold standard treatment. As pointed out in a previous post, for a long time surgeons have been using the decidedly non-scientific and non-clinical metric of “50% decrease in sleep breathing events” as a marker of success. It is difficult to imagine how anyone could imagine declaring a procedure that drops the AHI from 41 to 20 as anything resembling success and certainly has no relationship to the clinical construct of “optimal” treatment. Yet, years from now, I would not be surprised that the very idea of PAP might fall into such disrepute, these older and less valid benchmarks will somehow be declared the new gold standard of OSA/UARS treatment. Regrettably, that’s how government regulators and insurers want the public to view these things, so they can continue their push to see more contraction in sleep medicine services.

Ultimately, the convergence of all these changes in these fields will result in patients clamoring for better care, as one example through add-ons to their current, less optimal care with surgery, dental devices and of course mediocre responses to PAP.

The most recognizable case in point was the addition of REMZzzs mask liners and Pad-a-Cheek mask liner systems that dealt directly with the discomfort and pain caused by many masks. NDS therapy appears to represent greater potential, because it can serve as both an add-on as well as a stand-alone (at least temporarily) system for dissatisfied PAP consumers, OAT users or post-surgical patients still in search of more benefits 

Many of these patients will be driven to explore and experiment with add-ons as they realize the sub-optimal results they are receiving are not the optimal results they’ve been told they are receiving. In politics as elsewhere, this process is call “dumbing down.” Its purpose is to literally have people believe what they are getting is at a level of quality much higher than what they are actually receiving. One of the most glaring examples of this phenomenon is when a particular insurance company incessantly touts its high quality of care in all its promotional efforts while on a local level you may find thousands of unhappy consumers who know first-hand the insurer’s primary focus is not quality of care. Only when a cascade preference (the phenomenon where a whole bunch of people realize that what they know privately is actually the same piece of information held by thousands of other people) erupts would you then suddenly witness that the insurer loses a ton of business at the local marketplace.

We are talking now about a cascade preference in the opposite direction when patients finally realize they need and should be receiving more gains from their treatment. At the most expensive level, this change will be directly related to advanced PAP devices, whereby ABPAP and ASV will be universally accepted as head and shoulders above CPAP devices.

At the conservative level, the use of NDS and related nasal patency treatments, mostly commonly treatments for allergic rhinitis, nonallergic rhinitis, and rhinosinusitis, will probably emerge much faster in this developmental phase, not only because of the pronounced cost-effectiveness, but the greater ease of marketability. As you may recall from our nasal breathing video series on www.sleeptreatment.com , we promote a zero tolerance policy regarding nasal congestion or nasal patency issues. We declare there is no such thing as an optimal response to PAP therapy unless a patient can attain a state of perfect nasal patency.

In our research paper published in Sleep & Breathing, we discussed how the overwhelming proportion of patients with sleep disorders of any type, not just sleep breathing conditions, suffer from either allergic or nonallergic rhinitides or both. Thus, just by sheer numbers, a cascade preference involving the use of NDS and related nasal patency treatments seems like a very promising area of conservative clinical treatment options for innumerable patients. 

Finally, in our publication more than one decade ago, we conducted the first and only randomized controlled trial of NDS, which clearly demonstrated that insomniacs with suspected mild OSA or UARS reported notable decreases in symptoms just after one month of NDS use. Here, then, is a perfect example of NDS applied to patients who see themselves as other than classic OSA patients, because none of the sample included people who believed sleep breathing had caused their insomnia.

In the next post, I would like to delve into some research ideas on how to promote the use of this conservative approach to sleep disorders treatments. Although creating new conventional wisdom and developing astute marketing strategies often prove more important in the short-term to advance these therapeutic options, long-term we find that innovative research complements these commercial interests.


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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