There are currently not many options available in the market to relieve people who snore, their suffering or the suffering of someone who is within earshot. But a new device approved by the U.S. Food and Drug Administration on Friday, a game exchanger for the misery of bedtime, and the best is that you do not even have to wear it at night.
The eXciteOSA device is the first of its kind to treat snoring and mild obstructive sleep apnea, a condition that causes a person’s airway to be frequently blocked while sleeping, by stimulating the tongue’s muscle. While many other snoring and sleep apnea treatments are aimed at the nose and are aimed at keeping the airways of the nostril clean, the tongue is just as guilty behind the problem as it can collapse backwards while a person is sleeping and can prevent airflow.
To try to prevent this from happening, the eXciteOSA nozzle 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 to start over a period of six weeks, then once a week.
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 over 40dB) by 20% in 87 of the 155 patients involved in the assessment, per a press release. From a subgroup of patients who struggled with both snoring and mild sleep apnea, the device reduced the apnea-hypopnea index of each person, which measures the severity of obstructive sleep apnea, by an average of 48% in 41 of 48 patients. In terms of side effects, the FDA that was most commonly observed was excessive salivation, discomfort in the tongue or teeth, tingling teeth, sensitivity to the dental filling, metallic taste, gagging and density in the jaw.
The eXciteOSA nozzle is currently only available by prescription and is intended for adults from 18 years of age who do not have problems or devices that are contraindicated, including pacemakers, implanted fits, temporary or permanent implants, dental braces and dental jewelry. It is also not intended to treat severe obstructive sleep apnea, and patients need to undergo an extensive dental examination, according to the agency.
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Obstructive sleep apnea is a common 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 The U.S. Department of Health and Human Services found that an estimated 936 million adults between the ages of 30 and 69 worldwide had mild to severe obstructive sleep apnea.
‘Obstructive sleep apnea not only affects the quality of sleep, but can also have other serious health consequences if left untreated. Today’s authorization offers a new option for thousands of individuals who experience snoring or mild sleep apnea, ‘said Dr. Malvina Eydelman, director of the Office of Ophthalmology, Anesthesia, Respiratory, ENT and Dental Devices at the FDA’s Center for Devices and Radiological Diseases, said. Health, in the agency’s press release.
Although snoring can undoubtedly be irritating to those who are forced to listen to the racket throughout the night (here I am not speaking from experience …), it is not necessarily an indication of a more serious sleep disorder, although many of the symptoms overlap with obstructive sleep apnea. However, this is a common case: About 45% of adults snore occasionally, while a quarter of all adults snore regularly. According to John Hopkins researchers.
Of course, the eXciteOSA mouthpiece is not the holy cure for these problems, but it has shown promising results so far and may inspire future treatments that try new methods to stifle these sleep conditions in the germ. And I’m sure someone dealing with a snoring partner agrees that any solution that leads to more Zzzs and fewer earplugs is a good solution.