Currently, there are not many options available in the market to help people who snore relieve their suffering or the suffering of anyone caught in sight. But a new gadget approved by the U.S. Food and Drug Administration on Friday could be one game changer for those bedtime problems, and the best part is that you don’t even have to wear it at night.
The eXciteOSA device is the first of its kind authorized to treat snoring and mild obstructive sleep apnea, a condition that involves a person’s airways being routinely blocked while sleeping, stimulating the muscle of the tongue. a person. Although many other treatments for snoring and sleep apnea are aimed at the nose and aim to keep the airways clear of the nostril, the tongue is to blame for the problem as it can collapse backwards while a person sleeps and blocks the flow of air.
To try to prevent this from happening, the eXciteOSA nozzle uses four electrodes, two above the tongue and two below, to provide neuromuscular stimulation using a series of electrical pulses with intermediate rest periods. Patients use the device on the 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 developer of the device. The agency said the device reduced loud snoring (more than 40 dB) by 20% in 87 of the 155 patients involved in its assessment, for a press release. From a subset of patients who struggled with both snoring and mild sleep apnea, the device reduced each person’s apnea and hypopnea rate, which measures the severity of obstructive sleep apnea. in 48% on average in 41 of 48 patients. As for side effects, the most common observed by the FDA were excessive salivation, discomfort in the tongue or teeth, tingling of the tongue, sensitivity to tooth filling, metallic taste, gagging, and tension in the jaw.
The eXciteOSA mouthpiece is only a prescription for now and is intended for adults over the age of 18 who do not have problems or contraindicated devices, such as pacemakers, implanted rhythm cables, temporary or permanent implants, dental appliances and dental jewelry, others. It is also not intended to treat severe obstructive sleep apnea and patients should undergo a complete dental examination before starting treatment, 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 conditions, cancer, and cognitive and behavioral disorders, according to the FDA. 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 experience mild to severe obstructive sleep apnea worldwide.
“Obstructive sleep apnea not only affects sleep quality, but can have other serious health impacts if left untreated. Today’s clearance offers a new option for thousands of people who experience snoring or apnea mild sleep, ”said Dr. Malvina Eydelman, director of the Office of Ophthalmic, Anesthetic, Respiratory, ENT, and Dental Devices at the FDA’s Center for Devices and Radiology. Health, in the agency’s press release.
While snoring can certainly be annoying for those who are forced to listen to this racket all night (totally not 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 adults snore regularly. in accordance with John Hopkins researchers.
The eXciteOSA mouthpiece is obviously not the cure for the Holy Grail for these issues, but so far it has shown some promising results and could inspire future treatments that try new methods to eliminate these sleep conditions in the outbreak. And I’m sure anyone dealing with a snoring partner will agree that any solution that leads to more Zzz and fewer earplugs is good.