By Matthew Anastasi, BS, RST, RPSGT
Located in the tiny village of Merida, Venezuela is Heladería Coromoto, an ice cream parlor, known for offering a Guinness Record for most flavors of ice cream in the world (860 varieties). Despite our sometimes homogeneous view of the condition, sleep-disordered breathing (SDB) has many varieties (though not enough to challenge Coromoto’s total). Obstructive Sleep Apnea (OSA) is by far the most common of the SDB disorders, but its subgroup positional (supine) dependent OSA (POSA) is arguably the most undertreated (if not under-appreciated) form.
What is POSA?
Positional OSA is a type of OSA in which the Apnea/Hypopnea Index (AHI) is twice as great in the supine position compared to non-supine sleep, as first defined through the Cartwright criteria (Cartwright, 1984). (And a non-supine AHI of < 5 gives further support for a POSA diagnosis (Eijsvogel, et al., 2015).)
How common is POSA?
A 2018 study (Heinzer, et al.) revealed that positional OSA was present in 53% of the middle to older age population and in 75% of OSA subjects. Many sleep professionals would be surprised to know that up to nearly half of their patients diagnosed with OSA may be more accurately defined as having exclusively positional OSA (ePOSA) (Heinzer, et al., 2018). The typical POSA patient has milder OSA, is less heavy, younger and with no gender differences (Maher, 2019).
How is POSA treated?
The recipe that makes POSA is the “right” mixture of gravity and anatomy, which yields OSA (Maher, 2019). This means that the most effective method for addressing positional events is equally simple: keep the patient off the back!
Most Positional Therapy (PT) treatments are prescription-based and fall into two established treatment categories: a) a physical obstruction, and, b) devices which continuously monitor a patient’s position and prompt the sleeper to reposition.
How useful is PT?
Current treatments for POSA are similar in effectiveness and have better adherence than PAP therapy, but most of the original research on PT took place over a decade ago and examined pillows and the original tennis ball technique (TBT), which is an antiquated treatment that has poor compliance (Bignold, et al., 2009) and resulting poor efficacy in treating POSA. First-generation research results on PT (Kushida, et al., 1999; Zuberi, et al., 2004) and anecdotal cases of patients sleeping on the tennis balls (and having poor outcomes) serve as the foundation for the AASM’s PT recommendation as a secondary or supplementary treatment for OSA in the Practice Parameters for OSA of 2006 (Morganthaler, et al.), which continues to influence treatment recommendations to this day.
With the introduction of new PT devices have been the emergence of new research that paints a very different picture for PT: one that displays increased compliance and effectiveness. For example, Berry, et al. (2019) demonstrated non-inferior POSA treatment efficacy and increased compliance using a new chest-based PT device compared with APAP, for subjects with ePOSA. In addition, Levendowski, et al. (2014) showed similar effectiveness in reducing POSA using a new neck-based PT device and found 88% compliance in patients using the device (Levendowski, et al., 2018).
Why is PT not a “big three” OSA treatment?
Given the data, you may be asking why PT is not the first-line care, up there with PAP, OAT (oral appliance therapy) and surgery (upper airway and nerve stimulators)? Some doctors don’t trust it, and with the history of poor compliance driven by years of TBT use, and the long-standing acceptance of it as a secondary treatment for OSA, this is understandable. There is a saying about old habits…they die hard.
There are two other reasons often cited for the underreporting of POSA diagnoses in our profession:
- In the real world, the diagnostic part of splits are so short (i.e., during a split there is often less than 30 minutes supine sleep during a 2-hour diagnostic) that it is only after a patient fails PAP that we look retrospectively to identify causes. In split study cases, AHI doesn’t accurately reflect the nearly half of OSA patients in our care with latent ePOSA.
- Reimbursement has played a role: PAP therapy is looked at first followed by OAT because they are likely reimbursable.
Despite the prevailing winds, the emerging technologies in the following three devices are poised to uncover the potential for PT treatments, as they use a new combination of technological, neurological and physical approaches. The first is a physical obstruction device, and the second and third are electronic-based devices.
slumberBUMP (slumberBUMP)
What is slumberBUMP?
According to Shad Morris, DMD, owner and inventor of the device, slumberBUMP is a PAP-alternative and conservative treatment for sleep-disordered breathing. It consists of a back-centered comfortable air bladder held in place by a breathable strap which prevents supine sleep. There is no prescription required and the cost is $79. It is an FSA/HSA-approved product and most major medical has paid including Tricare and UnitedHealthcare.
How does slumberBUMP work?
The original TBT was first recommended over ten years ago (Skinner, et al., 2008) and delivers negative reinforcement (i.e., pain) from a tennis ball taped to the back to promote non-supine sleep. Unsurprisingly this PT approach proved intolerable over the long-term (Bignold et al., 2009) and the treatment approach has colored the reputation of PT ever since.
The first-generation introduction of slumberBUMP in 2013, however and the improved second-gen device offered today, was developed as a more gentle response to the PT of old and uses materials and an air bladder which gives more of a “nudge” to return supine than a jarring, painful experience of laying on a tennis ball. And the third-gen will consist of newer materials, newer attachments and be even more tolerable and comfortable (think “first-class” versus “coach”).
What makes slumberBUMP unique?
43% of medical devices are FDA-approved as Class II devices. This classification was intentionally not sought after by slumberBUMP. This decision was designed to make the treatment of sleep-disordered breathing more accessible for patients in two ways: a) an order is not needed, and b) without the regulatory process involved in an FDA application, the cost for the device was able to be kept low.
How can slumberBUMP be a “game-changer” for the treatment of OSA?
The air bladder is collapsible and no power is needed, which makes the product safe and ideal for travel such as in the case for military deployment Despite the lack of FDA approval, which means slumberBUMP is not able to make medical claims about the treatment of a disorder such as OSA, it is functionally in the category of a physical obstruction PT device. The current research (Eijsvogel et al., 2015) on gentle approaches to physical obstruction PT is showing that compliance is at least as good as PAP, which indicates approaches like slumberBUMP merit a fresh look. It is the least expensive approach explored here and without the need for a prescription, it is the most accessible treatment for sleep-disordered breathing.
Positional OSA is about gravity so any degree the sleep medicine field can lessen the effects such as with an accessible product such as slumberBUMP, the better outcomes patients will have.
NightBalance (Philips)
What is NightBalance?
According to Philips territory manager Emerson Kerr, NightBalance is a palm-sized vibrotactile device that is worn in the center of a soft chest strap. As a Class II medical device, a prescription is required and it costs $499. Philips is working with CMS to develop a code for insurance coverage, so it is currently not covered by major medical, but can be paid for through FSA/HSA accounts.
How does NightBalance work?
NightBalance uses an internal gyroscope to detect position, and a haptic device delivers a gentle vibration to the chest whenever it senses supine sleep. An algorithm determines when and how much vibration to administer, on a stepwise continuum from 1 to 7, that mimics the ramp on a PAP therapy machine. The vibration, therefore, delivers the minimum “nudge” needed to urge repositioning of the sleeper to his side, without disrupting sleep.
What makes NightBalance unique?
The chest location and construction of the strap should be very familiar to those in the field because it was developed by Philips and is similar in construction to PAP mask interfaces.
The developers of the device have created a cloud-based (though capable of use solely at the desktop for patient consults) platform to which all of your sleep data is automatically uploaded to a secure online portal. This is another area that Philips has perfected as a result of being a leader in the sleep diagnostics and treatment arena.
How can NightBalance be a “gamechanger” for the treatment of OSA?
The software interface, which is very user-friendly, allows you to follow your progress online and even on the device itself, helping you to stay motivated. NightBalance software can print out a report that shows how many times the patient moved to the supine position, how many times the device prompted the patient back to non-supine, and what intensity was necessary to achieve the result. This allows patients and sleep practitioners to evaluate for the first time how vibrotactile feedback can have behavioral results that impact real variables like AHI. This opens the doors to a new way to connect a patient’s goals and motivation to their health data—it is an exciting opportunity, indeed!
Smart Nora
What is Smart Nora?
Behrouz Hariri, co-founder & CEO, and Behzad Hariri, co-founder & COO, describe Smart Nora as a snoring solution device in which an inflatable padded insert located under the pillow provides a gentle nudge when snoring is detected, or a “pillow plus a gentle nudge.” It is validated through a 500-night research study by SleepScore Labs™, a company founded by ResMed, and has received FDA enforcement discretion (but it does not need an FDA-approval, which means the company may not make medical claims about their product). The device costs $359 but you will need to verify whether the product is HSA/FSA-approved.
How does Smart Nora work?
The mouse-shaped microphone “the Pebble” is attached overhead using a holder affixed with a non-residue adherent. It communicates snoring characteristics to a base unit under the bed. This base uses an algorithm that analyses a combination of decibel levels, frequency, and repetition to determine when to activate the pump which inflates the air bladder under the pillow.
The entire product is just over 5 pounds and fits in the felt bag for portability. The base works 2-3 nights on rechargeable batteries (7-10 for the microphone, also with rechargeable batteries) and at home can be plugged in permanently.
During an 8 hr. sleep period, the pillow remains at a normal height, unobtrusive when not needed. When early signs of snoring are detected the expander inflates and deflates over a span of 45 seconds to stimulate the neck muscles and prevent the partial collapse of the airway, resuming normal breathing. Once the cycle is done Smart Nora will standby and only react if snoring is detected. It uses what is called a “generalized” algorithm, not a “dynamic” one, which means it treats every night the same with no “biases” about the user’s snoring habits.
What makes Smart Nora unique?
Snoring pillows have been around for some time, but Smart Nora takes a different approach to sleep-disordered breathing not only because it uses gentle movement governed by a sophisticated algorithm, but because of the company’s focus on the user and the bed partner (think: snoring). In fact, it is for this reason that the microphone has a built-in ability to change to one of 5 levels based on bed partner sensitivity to snoring. The user still gets their own three-level adjustment of pad height based on the type of pillow used: foam is low; plush is high (up to four inches high).
Compared to pillow wedges, the company’s working principle is that it’s the nudge that is the most comfortable and effective way to stop snoring, but in a more sophisticated way than a bed partner would nudge (and with the sensitivity setting, activated at a threshold below which would awaken the bed partner). This is consistent with the previously-mentioned research on vibrotactile devices for POSA which use a “nudge” in place of pain.
How can Smart Nora be a “game-changer” for the treatment of SDB?
The product was developed using a consumer approach for those who wanted a contact-free solution that was easy to fit into their sleep routine. You use your own pillow and can sleep on your side back or stomach. In addition, you can place your head anywhere on the pillow.
The approachability of the design is its strength: you are not changing your sleep routine, not putting anything in your mouth; you keep your own pillow and you don’t change anything else about your routine. The company reports anecdotally that many couples who began sleeping in separate bedrooms due to snoring are now back in the same bedroom. The minimally-invasive nature of Smart Nora is why the product deserves a close look.
What does all this mean for my patients?
It takes a full strategy to make the treatment of exclusive POSA or OSA with a positional component work. You not only need to consider the “big three” but recognize that there is now a place for positional therapy, not only because of the potential to combine therapies, the mitigation of pain from physical obstruction approaches, and the potential for sophisticated interventions and behavioral insights that vibrotactile devices afford, but most importantly because the research and anecdotal evidence points to latent positional sources for OSA as well under-represented and undertreated in the practice of sleep medicine.
Consider these applications:
- The pregnant patient in her third trimester who attempts to sleep in the lateral position
- The post-surgical patient taking opioids, or other known respiratory-suppressants, to manage pain
- The patient with intolerance to high PAP pressures who may be able to find a lower therapeutic range if they are able to avoid supine sleep
- The patient who experiences a 50% reduction in AHI with OAT (which is typical), but because she has a positional component to her sleep can experience a further reduction in AHI combining the OAT with PT
Ask yourself whether the patient is the right candidate for one of these devices. The bottom line is whether it is going to help the patient. The treatment may wind up being the solution to the flavor of SDB that your patient presents, or one more important piece of the puzzle.
References
American Academy of Sleep Medicine. (2014). International classification of sleep disorders, 3rd ed. Darien, IL.
Berry R. B., Uhles M. L., Abaluck B. K., Winslow D. H., Schweitzer P. K., Gaskins R. A. Jr, Doekel R. C. Jr & Emsellem H. A. (2019). NightBalance sleep position treatment device versus auto-adjusting positive airway pressure for treatment of positional obstructive sleep apnea. J Clin Sleep Med. 15(7), 947–956.
Bignold, J. J., Deans-Costi, G., Goldsworthy, M. R., Robertson, C. A., McEvoy, D., Catcheside, P. G., & Mercer, J. D. (2009). Poor long-term patient compliance with the tennis ball technique for treating positional obstructive sleep apnea. JCSM, 5(5), 428–430.
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Maher, E. (2019, September 6). AAST OSA Sleep Therapies Panel, The AAST 2019 Annual Meeting, St. Louis.
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