Advances in Therapeutic Devices for Sleep Apnea

Sleep apnea treatment may be simple, though uncomfortable or includes unwanted side effects. Frost & Sullivan has taken notice of technological advances that are making conventional systems more comfortable, quieter, and less likely to cause side effects.

If only we could all get a good night’s sleep. The full 7 hours recommended by the American Academy of Sleep Medicine and the Sleep Research Society is, unfortunately, but a dream for a large swath of the U.S. adult population: at least 25% of all people 18 and older report that they don’t get enough sleep. That percentage almost doubles in some states, according to the U.S. Centers for Disease Control and Prevention, often following the same path of states in which a greater percentage of the population reports associated risk factors including obesity, physical inactivity, excessive alcohol use or smoking.

Sleep apnea is a common cause of sleep interruption. Treatment may be as simple (yet difficult) as a lifestyle change or the use of a continuous positive airway pressure (CPAP) device. CPAP therapy, however, involves wearing a mask that some patients find to be uncomfortable or the cause of dry mouth, runny or stuffy nose, claustrophobia, or even pressure ulcers. Machine noise also has been a problem that has affected therapy compliance.

Frost & Sullivan, during its research of the sleep apnea therapeutics market, has taken notice of technological advances that are making conventional systems more comfortable, quieter, and less likely to cause side effects. Alternative therapies are also emerging in response to patients’ non-compliance with conventional CPAP treatment. They include oral appliances and minimally invasive neurostimulators. Interesting products and other developments are summarized below.

ResMed (San Diego, Calif.)

ResMed has a strong position in the market and offers CPAP, automatically adjusting (APAP) and bi-level (BiPAP) machines. Its AirSense 10 Elite CPAP device is a premium product designed for comfort and simplicity. Features include SmartStart, which allows a person to begin treatment by simply breathing in rather than pressing a button, and AutoRamp, which begins therapy at low pressure to help the user fall asleep and then gradually increases it to the prescribed level. AirSense devices include a heated humidifier to prevent dry nose and mouth, and cellular connectivity that allows physicians to review nightly data, remotely troubleshoot or change device settings, and detect indications of other problems that may require further treatment. 

Nyxoah (Mont-Saint-Guibert, Belgium)

The medical device company with manufacturing units in Israel has developed the Genio, an ultra-small neurostimulator that is implanted close to the nerves of the tongue muscle in a minimally invasive surgery that takes about 45 minutes. The Genio is 16 times smaller than other available neurostimulators that can treat sleep apnea and has a life expectancy of 12 years—about double that of other implants. It is powered by a rechargeable activation chip that is attached to a disposable adhesive patch each night and placed under the chin. The implant is able to detect when the patient’s tongue begins to fall back and obstruct the airway, initiating electrical stimulation of the hypoglossal nerve. In the morning, removal of the patch effectively disables the neurostimulator, and the chip is plugged into a charging unit. The implant’s small size and ease of use is a boon for patients who find CPAPs uncomfortable and unreliable.

The company is still awaiting regulatory approvals to sell the product in Europe. An active clinical trial of the Genio in the United States is scheduled for completion this month. 

Oral Device Therapies

Interest in oral appliances for obstructive sleep apnea has been increasing because they are quieter and more comfortable, more portable, and less expensive than conventional PAP devices, with no pressure sensation or mouth drying effect. A growing body of evidence is demonstrating their benefits, though they are currently used more frequently in Europe than in the United States. 

The apnea-hypopnea index (AHI) is used to indicate the severity of sleep apnea. It is represented by the frequency of apneic and hypopneic events per hour of sleep. Numerous clinical trials that compared CPAP treatment with oral appliances clearly suggest that with CPAP use, a reduction in AHI, sleep arousal index and minimum oxygen saturation is witnessed if patients are in 100% compliance, i.e., 6 hours per night and at least 5 days per week. The discomfort posed by CPAPs, however, typically reduces compliance to the 50 to 60% range. Oral device therapy does not suffer from patient intolerance, allowing for greater compliance when compared with CPAP. Results have demonstrated that oral appliance devices help reduce the overall AHI level and improve the quality of sleep by reducing the sleep arousal index. The average patient replaces a custom oral appliance every 3 to 5 years, whereas standard appliances rarely last 2 years with continued use. 

The Road Ahead

Frost & Sullivan believes that computer-aided design and manufacturing, the inclusion of diagnostic and compliance monitoring technologies, improvements in plastics, and greater adoption of digital scanners will result in more innovations that improve comfort and, ultimately, compliance. 

While individual products are unlikely to change much in the next few years, better patient education and clinician training, as well as the integration of more physician and dental practices, will propel acceptance of oral appliance therapy. 

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