By Ernie Mundell and Steven Reinberg HealthDay Reporters
MONDAY February 8, 2021
The US Food and Drug Administration on Friday approved the marketing of a new “tongue strengthening” device to reduce snoring in patients with mild obstructive sleep apnea.
Unlike devices used during sleep, this prescription device is used while awake and is designed to stimulate and strengthen the tongue so that it does not collapse backwards and obstruct the airways during sleep. sleep.
“Obstructive sleep apnea not only impacts the quality of sleep, but can also have other serious health effects if left untreated,” said Dr. Malvina Eydelman, director of the office of ophthalmic, anesthetic, respiratory, ENT and dental devices at the FDA’s Center for Devices and Radiologic Health, said in a press release from the agency.
The authorization of the new device “offers a new option for the thousands of people who suffer from snoring or mild sleep apnea,” Eydelman added.
An expert who treats sleep apnea, however, doubted the device would have a major effect.
“The device is only useful in patients with mild obstructive sleep apnea, and the applicability of the device remains to be seen, as the numbers suggest only minor improvements in patients with already existing disease. benign, ”said Dr Thomas Kilkenny. He directs sleep medicine at Staten Island University Hospital in New York.
The device, called eXciteOSA, is a tongue muscle stimulator that gives neuromuscular stimulation to the tongue and is intended for adult patients. According to the FDA, the device works by giving electrical muscle stimulation through a mouthpiece that sits around the tongue.
The mouthpiece has four electrodes, two located above the tongue and two located below the tongue. Muscle stimulation is given in a series of electrical pulses with periods of rest in between. It is used for 20 minutes once a day for six weeks, and once a week thereafter.
The FDA tested the safety and effectiveness of eXciteOSA in 115 patients who snore, including 48 with snoring and mild sleep apnea.
Overall, the time spent snoring was reduced by more than 20% in 87 out of 115 patients, the agency said. And, in patients with mild obstructive sleep apnea in particular, snoring was reduced by 48% in 41 of 48 patients.
The most common unwanted side effects were excessive salivation, discomfort in the tongue or teeth, tingling of the tongue, tooth filling sensitivity, metallic taste, gagging and a tight jaw, the agency said. .
Dr. Steven Feinsilver heads the Center for Sleep Medicine at Lenox Hill Hospital in New York City. He agreed with Eydelman that the new device might have limited use, although new sleep apnea therapies are badly needed.
“Sleep apnea is about as common as diabetes – around 4% of the adult population,” Feinsilver said.
“Currently, the most effective form of treatment is to sleep with a [mask] device that pressurizes the back of the throat to keep it open (CPAP), but this is not always well tolerated, ”he noted.
“We know that muscles in the upper respiratory tract like the tongue actively work to keep the airways open during sleep, and it’s likely that these muscles could be trained or strengthened,” Feinsilver reasoned. “This device appears to be a simple way to increase muscle tone in the tongue.”
Yet eXciteOSA “has obviously only been used in patients with very mild sleep apnea. It is an interesting avenue for a new form of treatment, but I would need to see its effect on those with suffer from significant sleep apnea rather than just improve snoring, ”Feinsilver says.
Kilkenny agreed, noting that while the device has been shown to reduce some snoring, it may not translate to real improvement in sleep apnea. “There is no comment regarding the clinical improvements in the condition of the patients,” he said.
According to the FDA, patients must undergo a dental exam before using the device. The eXciteOSA device is not recommended for patients with pacemakers or implanted electrodes; those with temporary or permanent implants, braces, prostheses / restorations / intraoral metal appliances or dental jewelry in the mouth; women who are or may be pregnant; or those who suffer from ulcers in or around the mouth.
The eXciteOSA device is also not intended for patients with sleep apnea measured with an apnea-hypopnea index of 15 and above. Mild sleep apnea is a score over five but less than 15.
The device is manufactured by Signifier Medical Technologies, LLC.
To learn more about sleep apnea, visit Sleep foundation.
SOURCES: Steven H. Feinsilver, MD, director, Center for Sleep Medicine, Lenox Hill Hospital, New York City; Thomas Kilkenny, DO, director of sleep medicine, Staten Island University Hospital, New York; US Food and Drug Administration, press release, February 5, 2021
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