There are not many options currently available on the market to help people who snore alleviate their suffering or the suffering of anyone who is stuck in their ears. But a new gadget approved by the US Food and Drug Administration on Friday could be a game changeable for those bedtime misfortunes, 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 to treat snoring and mild obstructive sleep apnea, a condition that involves blocking a person’s airway normally while sleeping by stimulating a person’s tongue muscle. While many other treatments for snoring and sleep apnea target the nose and aim to keep the nasal airways clear, the tongue is just as guilty behind the problem as it can collapse back while a person sleeps and blocks the flow of air. .
To try to prevent this, the eXciteOSA mouthpiece uses four electrodes – two above the tongue and two below – to provide neuromuscular stimulation through a series of electrical impulses with rest periods between them. Patients use the device on their tongue for 20 minutes a day for a period of six weeks to begin, then once a week thereafter.
On Friday, the FDA granted marketing authorization to Signifier Medical Technologies, the device’s developer. The agency said the device reduced loud snoring (over 40 dB) by 20% in 87 of the 155 patients involved in its assessment, on a press release. From a subset of patients who struggled with both snoring and mild sleep apnea, the device reduced each person’s apnea-hypopnea index, which measures the severity of obstructive sleep apnea by an average of 48% at 41%. out of 48 patients. Regarding side effects, the most commonly observed by the FDA were excessive salivation, discomfort of the tongue or teeth, tingling of the tongue, sensitivity to tooth filling, metallic taste, clogging and tightness of the jaw.
The eXciteOSA mouthpiece is prescribed only for the time being and is intended for adults 18 years of age and older who do not have contraindicated problems or devices, which include pacemakers, implanted pacing cables, temporary or permanent implants, dental appliances, and dental jewelry, among others. It is also not intended to treat severe obstructive sleep apnea, and patients should have a full dental examination before starting treatment, according to the agency.
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Obstructive sleep apnea is a predominant sleep disorder that can 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 US Department of Health and Human Services found that approximately 936 million adults between the ages of 30 and 69 suffer from mild to severe obstructive sleep apnea worldwide.
Obstructive sleep apnea not only affects the quality of sleep, but can have other serious health effects if left untreated. Today’s permit offers a new option for thousands of people suffering from snoring or mild sleep apnea, “said Dr. Malvina Eydelman, director of the Office of Ophthalmic, Anesthetic, Respiratory, ENT and Dental at the FDA’s Center for Devices and Radiology. Health, in the agency’s press release.
Although snoring can undoubtedly be annoying for those forced to listen to the rocket throughout the night (totally not speaking from experience here …), it is not necessarily indicative of a more severe 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. conformable Researchers John Hopkins.
Obviously, the eXciteOSA mouthpiece is not the cure for the holy grail for these problems, but it has shown some promising results so far and could inspire future treatments that try new ways to stifle these budding sleep conditions. And I’m sure anyone dealing with a snoring partner will agree that any solution that leads to more Zzzs and fewer earplugs is a good one.