Have Snoring…Will Treat It

There is no gold standard treatment for snoring—yet—but clinicians and patients have a growing menu of options that can cover most of its causes.

While occasional snoring is a nuisance, chronic snoring can have serious effects on sleep, relationships, and cardiac health—even if not tied to sleep apnea.

Research led by Per Stal, associate professor and research leader at the Department of Integrative Medical Biology at Sweden’s Umeå University, has identified that snoring causes significant long-term injuries, including developing swallowing dysfunction and making patients more susceptible to developing obstructive sleep apnea (OSA). His research notes that snorers and sleep apnea patients have neuromuscular injuries in the upper respiratory tract both at the structural and molecular levels. Recurrent snoring doesn’t allow for these damaged tissues to heal.1

What’s more, preliminary research led by Adrian Curta, MD, a radiology resident at Munich University Hospital in Germany, has identified that women who snore are at much greater cardiac risk than men.2 “It is unfortunately still unclear why women are more susceptible to developing cardiac-related symptoms,” Curta says. He suspects many of the study subjects with cardiac alterations may also have undiagnosed OSA.

Beyond long-term significant health issues, snoring can have immediate consequences as well.

“Sleep is a critical element of everyone’s health, and poor sleep can negatively impact many aspects of a person’s wellbeing,” says Mark Aloia, PhD, global lead for behavior change with Philips Healthcare and associate professor of medicine at National Jewish Health in Denver, Colo. “Snoring is a prevalent sleep condition that not only affects the afflicted person but also impacts their most personal relationships. According to research, more than 40% of the global population snores, with side effects including excessive tiredness for both snorers and their bed partners. Because of the scope of influence a snorer can have on the quality of sleep for those around them, snoring—not related to sleep apnea—is an important challenge that should be addressed on its own.”

While CPAP is commonly referred to as the gold standard for treating sleep apnea, there is no corresponding therapy for snoring. But clinicians do have a number of options to fit to the cause of each patient’s snoring and lifestyle. Here are some of the diverse antisnoring options available in five emerging treatment modalities.

Muscle Toning

One cause of snoring is excessive loss of throat muscle tone during sleep—resulting in collapse and vibration, according to Anshul Sama, BMedSci, BMBS, FRCS (Gen Surg), FRCS (OTOL), chief medical officer for device Snoozeal. Preventing this collapse is the premise behind muscle toning.

Two examples of muscle toning treatments are Snoozeal, made by Signifier Medical Technologies, and an app named Soundly that was developed in partnership with the University of Minnesota’s Sleep Centers and the Medical Devices Center.

Snoozeal

Snoozeal uses low intensity electrical pulses to train the tongue muscles and prevent snoring.

Snoozeal—for which Signifier Medical Technologies expects to file for de novo FDA approval later this year—consists of an ergonomically designed silicone mouthpiece that fits over the tongue. The device is designed for use during the day for 20 minutes for about six weeks, with maintenance treatments of once to twice a week. During treatment, Snoozeal uses electrical current to stimulate and improve muscle function. The device works in conjunction with an app with four plans.

Based on clinical trials of the device there is no loss of effectiveness due to weight, according to Sama.

Like all snoring treatment devices, Snoozeal is not a panacea. “It is not recommended for children below age 18 years, pregnant women, individuals with oral implants, or patients with implanted electrodes such as pacemakers,” advises Sama.

Snoozeal will be released as a prescription device, according to Sama, and will likely be available through any clinician who treats patients for snoring, including ear-nose-throat surgeons and sleep and respiratory physicians.

For patients who want to tone their tongue muscles without a device, there’s the app-based Soundly, which guides patients through a series of myofacial and orolingual exercises.

The genesis of the app came when Brian Krohn, PhD, CEO of Soundly, read a paper about how patients who were prescribed playing the didgeridoo, an Australian aboriginal wind instrument, lessened their snoring.

Through his research, Krohn and his colleagues discovered that patients could strengthen their tongue muscles and lessen their snoring through a regimen of “eee” and “aaw” sounds. “Eee” pushes the tongue forward and “aaw” pushes it back.

“It’s like pushups for the back of the throat,” Krohn says. “We distilled down the therapies to the essentials.”

But knowing that exercises in and of themselves would likely be abandoned by patients quickly, the Soundly app gamifies the treatment. Patients play a Space Invaders-like game, controlling a character who gets stronger as the patient gets stronger (or weaker if the patient misses a few days of treatment).

The ideal patient is someone whose snoring is caused by their tongue. The app has been available on the Apple App Store since October 2018—with an Android app anticipated to launch next summer—and costs $30 per year.

Krohn has applied for a grant to study Soundly as a means to improve CPAP compliance and is exploring it as a co-therapy with a mandible device, again to help improve compliance.

In-Office Procedures

From Zelegent Inc CEO Alexander Arrow’s point of view, there are flaws with both device-based snoring treatments and traditional surgical interventions.

Traditional nonsurgical treatments require a patient to wear a device, moving the mandible, which are only effective if the cause of snoring is related to the base of the tongue. Surgical intervention involves removing portions of the palate—along with the tonsils in some cases—and, while permanent, is extremely invasive and requires several weeks of recovery.

Zelegant elevoplasty

An Elevo suture implant is loaded on the tip of an Elevo suturing needle.

Zelegent offers a minimally invasive procedure called an elevoplasty. Developed by David Volpi, MD, FACS, a New York City snoring specialist and founder of eos sleep, and Yosef Krespi, MD, FACS, director of the Center for Sleep Disorders, and the NYHNI professor of clinical otolaryngology at Columbia University, elevoplasty can typically be done in as an in-office procedure with little to no prep.

It uses resorbable barbed sutures to lift the soft palate without surgery to shorten it, stiffen it to lessen the vibrations that cause snoring, and create secondary scarring to make it stiffer.

Recovery usually takes about two days. Pain typically resembles a strep-sore throat. While recovering patients can talk and eat a normal diet, Arrow recommends staying away from astringent food.

Arrow, who is also a medical doctor, describes the procedure as “a mini-facelift for the soft palate.” And, like a facelift, there will be a necessity for periodic touchups. After six months, the barbed sutures dissolve.

According to Arrow, the ideal patient is a non-apneic, non-obese patient who doesn’t want surgery or to wear an appliance. Elevoplasty currently is not covered by any insurance, but it is FDA 510(k) cleared.

Evaluation is as easy as the procedure. “You open your mouth and say ‘aahh’,” observes Arrow. “The beauty of the elevoplasty is that it’s quick, easy, and minimally invasive.”

Zelegent has entered into a partnership with Cook Medical, which sells the device on Zelegent’s behalf.

Positional Therapy

It’s not just a weak tongue or a loose soft palate that may be at the root of snoring. For some patients, it’s the position in which they sleep. Patients who primarily sleep on their back and snore several times a week may be good candidates for positional therapy.

Several positional therapies are tied to a device that gently vibrates, causing the patient to change positions while not waking up.

Snoring SmartSleep Relief Band

Philips’ SmartSleep Snoring Relief Band prompts users to sleep on their sides.

The SmartSleep Snoring Relief Band by Philips provides personalized feedback that helps users improve the quality of their sleep. The treatment consists of a sensor that is worn around the torso that continuously measures body position, detecting when the patient is sleeping on their back. If the band determines the patient to be sleeping on his or her back, it will give a gentle vibration cueing them to turn on their sides.

“The band is made to understand the wearer by measuring nightly sleep positions and assessing one’s specific behavioral change needs, and its self-learning algorithm automatically adjusts vibration intensity and pattern for lasting results,” says Aloia.

SmartSleep is a consumer device and is designed specifically for adult patients 25-54 who snore while sleeping on their backs—not side or stomach—and is to be used in conjunction with other therapies, such as CPAP. Because it’s classified as audio/video, information, and communication technology equipment, FDA approval is not required. It is scheduled for release in September 2019.

Snoring SnoreCoach

SnoreCoach is a wireless sleep position coach.

The SnoreCoach by Huneo is another vibrating device. Instead of a band, patients clip a small sensor on the neck of their sleep shirt. It gently buzzes if it senses that the patient is sleeping on their back.

“It’s similar to a sleeping partner’s nudge or elbow,” explains Matt Ryder, who heads business development for the company.
The device is tied to a smartphone app that also evaluates snoring and tracks improvement in the user’s sleep. The app has a number of parameters that can be set by the user.

The company is in the process of acquiring FDA approval for the SnoreTrack app to work as a screening tool for obstructive sleep apnea, but Ryder notes it can already help evaluate if the patient has positional snoring.

EPAP

Hüpnos founder and CEO Curtis Ray describes expiratory positive airway pressure (EPAP) as “CPAP’s junior cousin.” EPAP devices are designed to dilate the airways with the patient’s own air.

Ray admits his early experience with EPAP was less than ideal: “I woke up with a dry mouth; it really wasn’t comfortable.”
To that end, he created Hüpnos, which consists of sleep mask that helps to increase nasal airways and an artificial intelligence-powered app that analyzes the patient’s sleep and controls the mask.

Snoring Hupnos App

The Hupnos mask increases users expiration pressure to open airways and reduce snoring. It pairs with a smartphone app.

Ray is a Hüpnos user himself. “The eye mask is my respite,” he says. “It’s all about compliance and compliance is comfort.”
Hüpnos is available through the company’s website, and Ray says the company might pursue FDA 510(k) approval for sleep apnea “if enough interest were shown.”

Theravent also uses EPAP, in this case via strips fit over the nostril openings and help improve airflow, to limit vibrations and decrease instances of snoring.

While some users may find that using Theravent is uncomfortable initially, the company recommends trying it for a week to get used to it, likening it to starting a new fitness regime—it may be difficult to do at first, but once you get used to it, it’ll become a habit.

Theravent is an FDA-approved consumer device and is available without a prescription.

Nasal Breathing Promotion

Patients who need a nasal breathing promotion device are typically open-mouth snorers. There are several approaches that are used to treat this, including oral and nasal devices.

SomniFix is an oral device that closes the lips—leaving only a small vent in the middle of the device (a safety feature)—and encourages patients to breathe through their noses.

“The way you breathe affects your autonomic nervous system,” says SomniFix CEO Nicholas Michalak. “Breathing through your mouth triggers a fight or flight response. Changing your breathing can help you sleep.”

The device stays over the mouth with an adhesive designed for the delicate skin of the lips. Similar to Theravent, there is a about weeklong acclimation period.

In addition to improving snoring, SomniFix can help avoid tooth decay due to mouth dryness, according to Michalak. It can also benefit the non-snorer who sleeps with his or her mouth open, and there is also some evidence that it can help promote CPAP compliance, Michalak adds.

SomniFix is not a product for every mouth snorer, according to Michalak. If the patient has nasal issues, such as a deviated septum, it won’t work. In that case, chin straps or positional therapy might be a better therapy.

SomniFix is available without a prescription.

HALE, formerly known as AssistENT, is described as “contact lenses for your nose” by COO Ben Shey. The semi-disposable device fits inside the patient’s nose to help promote nasal breathing and can be left in place up to 10 days.

“HALE is physically improving airflow and increases that sensation,” Shey says. “The result is a much more comfortable, satisfying airflow.”

While the device, which features springy plastic with a soft material overlay, is yet to be released to the market—it’s set for 2020—it is currently undergoing a clinical trial at Johns Hopkins, and those interested in trying it can sign up on the website.

The device will be a consumer device in the same category as a Band Aid, meaning that it is exempt from FDA approval.

The company is in the process of developing a subscription model for the device, similar to a shave club. There are also plans to develop a cleaning kit, increasing the longevity of each HALE device.

RhinoMedPronto

Pronto’s dual action design combines a nasal dilator with the vapors of a proprietary blend of pure essential oils.

A new solution already on the retail scene comes from RhinoMed, which makes the nasal dilator Mute for snoring. The company just released the Pronto, which is a vapor inhaler with dual action. It both opens the nose to improve airflow and delivers soothing vapors from essential oil blends, helping both to foster natural, uninterrupted sleep and to clear nasal stuffiness, according to RhinoMed.

A Myriad of Solutions

There are numerous solutions available to patients who want help to stop or minimize their snoring.

While it is likely impossible to be familiar with every treatment—it is crucial to note that today’s sleep clinicians have an ever-growing menu of options to help their patients.

Having been accused of snoring, on occasion, contributing writer C.A. Wolski was most keen on learning about all of the options available put these accusations to rest while researching this article—much to the relief of his wife.

References

1. Shah F, Franklin KA, Holmlund T, et al. Desmin and dystrophin abnormalities in upper airway muscles of snorers and patients with sleep apnea. Respir Res. 2019 Feb 14;20(1):31.
2. Curta A, Hetterich H, Schinner R, Lee A, et al. Subclinical changes in cardiac functional parameters as determined by cardiovascular magnetic resonance (CMR) imaging in patients with sleep apnea and snoring: Findings from UK Biobank. Abstract presented at RSNA 2018.

from Sleep Review http://www.sleepreviewmag.com/2019/08/snoring-treatments/

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