There are currently not many options on the market to help people who snore alleviate their suffering, or the suffering of someone who stays within earshot. But a new gadget approved by the US Food and Drug Administration on Friday would be one game changer for those bedtime problems, and the best part is you don’t even have to wear it at night.
The eXciteOSA device is the first of its kind approved for the treatment of snoring and mild obstructive sleep apnea, a condition in which a person’s airways are routinely blocked while sleeping, by stimulating a person’s tongue muscle. While many other snoring and sleep apnea treatments target the nose and aim to keep the airways of the nostril clear, the tongue is just as much a culprit behind the problem as it can collapse backwards while a person is sleeping and have the airflow.
To prevent this, the eXciteOSA mouthpiece uses four electrodes – two above the tongue and two below – to deliver neuromuscular stimulation through a series of electrical pulses with rest periods in between. Patients use the device on their tongue for 20 minutes a day over the course of a six-week period to begin, and once a week thereafter.
On Friday, the FDA approved the commercialization of Signifier Medical Technologies, the developer of the device. The agency said the device reduced loud snoring (just over 40 dB) by 20% in 87 of 155 patients involved in the review, per a press release. Of a subgroup of patients struggling with both snoring and mild sleep apnea, the device lowered each person’s apnea-hypopnea index, which measures the severity of obstructive sleep apnea, by an average of 48% in 41 of 48 patients. As for side effects, the most common ones observed by the FDA were excessive salivation, tongue or tooth discomfort, tingling in the tongue, sensitivity to dental fillings, metallic taste, retching and tightness in the jaw.
The eXciteOSA mouthpiece is currently available by prescription only and is intended for adults 18 and older who have no contraindicated problems or devices, including pacemakers, implanted pacing leads, temporary or permanent implants, braces, and dental jewelry. Nor is it intended to treat severe obstructive sleep apnea, and according to the agency, patients should undergo a comprehensive dental examination before starting treatment.
G / O Media can receive a commission
Obstructive sleep apnea is a common sleep disorder that can potentially lead to serious medical conditions if left untreated, such as glaucoma, diabetes, heart disease, cancer, and cognitive and behavioral disorders, the FDA said. A study by the U.S. Department of Health and Human Services found that an estimated 936 million adults between the ages of 30 and 69 worldwide experience mild to severe obstructive sleep apnea.
“Obstructive sleep apnea not only affects sleep quality, but can have other serious health effects if left untreated. Today’s approval offers a new option for the thousands of people who suffer from snoring or mild sleep apnea, ”said Dr. Malvina Eydelman, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health, in the agency’s press release.
While snoring can undoubtedly be annoying for those who are forced to listen to that racket all night (not at all from experience here …), it is not necessarily indicative of a more serious sleep disorder, although many of its symptoms overlap with obstructive sleep apnea. However, it is a common problem: about 45% of adults snore occasionally, while a quarter of all adults snore regularly according to John Hopkins researchers.
The eXciteOSA mouthpiece is clearly not the holy grail cure for these problems, but it has shown some promising results so far and could inspire future treatments that try new methods to nip these sleeping conditions in the bud. And I’m sure anyone dealing with a snoring partner will agree that any solution that leads to more Zzz’s and fewer earplugs is a good one.