This FDA approved tongue stimulator can reduce snoring and sleep apnea

There aren’t many options currently available on the market to help people who snore relieve their pain or that of anyone who is stuck within earshot. But a new gadget approved by the United States Food and Drug Administration on Friday could be a Thu changer for those bedtime woes, and the best part is you don’t even have to wear it at night.

The eXciteOSA device is the first of its kind licensed to treat snoring and mild obstructive sleep apnea, a condition that involves a person’s airways blocking regularly while they sleep, by stimulating the muscle in the tongue. ‘one person. While many other snoring and sleep apnea treatments target the nose and aim to keep the airways in the nostril clear, the tongue is equally to blame for the problem, as it can collapse backwards for that a person is sleeping and blocking the flow of air.

To prevent this from happening, the eXciteOSA mouthpiece uses four electrodes – two above the tongue and two below – to deliver neuromuscular stimulation through a series of electrical pulses with periods of rest in between. Patients use the device on their tongue for 20 minutes per day over a six-week period to begin with and then once a week thereafter.

On Friday, the FDA granted marketing authorization to Signifier Medical Technologies, the developer of the device. The agency said the device reduced loud snoring (anything above 40dB) by 20% in 87 of the 155 patients involved in its assessment, per A press release. In a subset of patients who suffered from both snoring and mild sleep apnea, the device reduced each person’s apnea-hypopnea index, which measures the severity of obstructive sleep apnea. by 48% on average in 41 of 48 patients. Regarding side effects, the most common observed by the FDA were excessive salivation, discomfort of the tongue or teeth, tingling of the tongue, tenderness. to dental filling, metallic taste, gagging and tightness of the jaw.

The eXciteOSA mouthpiece is available by prescription only at this time and is intended for adults 18 years of age and older who do not have any problems or contraindicated devices, including pacemakers, implanted pacing leads, temporary or permanent implants, braces and dental jewelry, among others. It is also not intended to treat severe obstructive sleep apnea, and patients should have a complete dental exam before starting treatment, according to the agency.

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 problems, the FDA said. A study by the US Department of Health and Human Services found that approximately 936 million adults between the ages of 30 and 69 have mild to severe obstructive sleep apnea worldwide.

“Obstructive sleep apnea not only impacts the quality of sleep, but can have other serious health effects if left untreated. Today’s authorization 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 Ophthalmology, Anesthesia, Surgery respiratory tract, ENT and dental devices at the FDA’s Center for Radiological and Devices. Health, in the agency’s press release.

While snoring can undoubtedly be annoying for those who are forced to listen to this noise all night (totally not to mention the experience here …), it is not necessarily a sign of a blood disorder. more severe sleep, although many of its symptoms overlap with obstructive sleep apnea. . It’s a common problem, however: around 45% of adults snore occasionally, while a quarter of all adults snore regularly. according to John Hopkins researchers.

The eXciteOSA mouthpiece is obviously not the holy grail cure for these problems, but it has shown promising results so far and could inspire future treatments that try new methods to quell these sleeping conditions in the body. egg. And I’m sure anyone dealing with a snoring partner will agree that any solution that leads to more Zzz’s and less earplugs is a good solution.