Currently, there are not many options available on the market to help snoring people to relieve their suffering, or the suffering of anyone within earshot. But a new gadget approved by the US Food and Drug Administration on Friday could be a games exchanger for those bedtime issues, and the best part is that you don’t even have to use it at night.
The eXciteOSA device is the first of its kind released to treat snoring and obstructive light sleep apnea, a condition that involves blocking a person’s airway during sleep, stimulating a person’s tongue muscle. While many other treatments for snoring and sleep apnea target the nose and aim to keep the airways in the nostrils unobstructed, the tongue is to blame behind the problem as it can collapse backwards while the person sleeps and block the flow of air.
To try to prevent this from happening, the eXciteOSA mouthpiece uses four electrodes – two above the tongue and two below – to provide neuromuscular stimulation through a series of electrical pulses with rest periods between them. Patients wear the device on their tongue for 20 minutes a day over a six-week period to begin, and 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 evaluation, for example. a press release. From a subset of patients struggling 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% in 41 of 48 patients. As for side effects, the most common ones observed by the FDA were excessive salivation, discomfort in the tongue or tooth, tingling in the tongue, sensitivity of dental filling, metallic taste, choking and stiffness in the jaw.
The eXciteOSA mouthpiece is only prescribed for the time being and is intended for adults aged 18 and over who have no problems or contraindicated devices, which include pacemakers, implanted electrodes, temporary or permanent implants, orthodontic appliance and dental jewelry, among others. It is also not intended for the treatment of severe obstructive sleep apnea, and patients should undergo a comprehensive dental examination before starting treatment, according to the agency.
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Obstructive sleep apnea is a prevalent 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, said the FDA. A study by the United States Department of Health and Human Services found that about 936 million adults aged 30 to 69 years suffer from mild to severe obstructive sleep apnea worldwide.
“Obstructive sleep apnea does not only affect the quality of sleep, but it can have other serious health impacts if left untreated. Today’s authorization offers a new option for the thousands of individuals who have snoring or mild sleep apnea, ”said Dr. Malvina Eydelman, director of the Office of Ophthalmology, Anesthesia, Respiratory, ENT and Dental Devices at the Devices and Radiological Center FDA Health, in the agency’s statement.
While snoring can undoubtedly be irritating for those forced to hear that noise at night (not entirely speaking 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 Researchers John Hopkins.
The eXciteOSA mouthpiece is obviously not the Holy Grail cure for these problems, but it has shown some promising results so far and may inspire future treatments that try new methods to eliminate these sleeping conditions in the bud. And I’m sure that anyone who deals with a snoring partner agrees that any solution that leads to more Zzzs and fewer earplugs is good.