- The FDA has approved a device worn during the day that strengthens the tongue in an effort to reduce the snoring associated with mild sleep apnea.
- Experts note the device does not help people with moderate or severe sleep apnea.
- However, they say any assistance for people with relatively minor snoring issues is welcome.
If you strengthen your tongue, can you avoid having to use bulky equipment on your face to reduce snoring while you sleep?
Federal officials think there might be a way to do just that.
The Food and Drug Administration (FDA) last week
But the word “mild” is key, as sleep experts are skeptical the new “tongue strengthening device” will have much of an effect on anything beyond simple snoring.
Nevertheless, the eXciteOSA is billed as “the first daytime therapy that tackles the root cause of sleep disordered breathing by physiologically retraining the airway against collapse.”
The device, which is being developed by Signifier Medical Technologies, is an electrical tongue muscle stimulator that works through a mouthpiece that sits on the tongue.
The mouthpiece contains four electrodes that give a series of electrical impulses with rest in between. It’s used for 20 minutes once a day for 6 weeks, then once a week after the initial period.
“This is not likely to be a game changer,” Dr. Sujay Kansagra, the director of Duke University’s Pediatric Neurology Sleep Medicine Program and a sleep health expert for Mattress Firm, told Healthline. “Over the years, there have been numerous devices or techniques that claim to help with sleep apnea. Unfortunately, most are only partially effective and are not beneficial for moderate or severe sleep apnea. Similarly, it appears this device has only been tested on mild sleep apnea.”
“We need more evidence,” Kansagra added. “We know that facial muscle testing can be beneficial. But with sleep apnea, the area of blockage can be in multiple areas, including with the nasal passages and the palate. So even if you strengthen the tongue, it may not necessarily help with sleep apnea, if the obstruction is occurring elsewhere.”
The FDA tested the safety and effectiveness of the eXciteOSA in 115 people who snored, including 48 with snoring and mild sleep apnea.
Researchers said the device reduced the amount of time spent snoring more than 20 percent in 87 patients. In those with mild obstructive sleep apnea, snoring was cut by 48 percent in 41 of 48 patients.
The most common adverse side effects were excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging, and tight jaw.
“It’s a great, novel option,” Dr. Abhinav Singh, the facility director of the Indiana Sleep Center, told Healthline. “It relies on a verified pathway of increasing tone in the upper airway muscles, namely, the tongue muscles that make up the back of the airway.”
“The pros are: It’s over the counter and it’s not worn at night, unlike CPAP. It’s effective in reducing snoring and breathing pauses by 50 percent,” Singh said.
“The cons: It’s not for moderate or severe cases of obstructive sleep apnea. Long-term studies aren’t available yet,” he added. “The patients in the trial were small in number and not very heavy, with lower body mass indexes.”
Experts stress sleep apnea is much more than just snoring.
“You can snore without having sleep apnea and people with sleep apnea don’t necessarily snore,” said Dr. Carl W. Bazil, the director of epilepsy and sleep at Columbia University College of Physicians and Surgeons in New York. “Also, snoring alone doesn’t necessarily interfere with your sleep or cause health problems — although it may well interfere with your bed partner’s sleep.”
“There is progress in awareness to some extent, but there are a great many people who have undiagnosed sleep apnea and think that they just need more sleep,” Bazil told Healthline. “It’s also well known that untreated sleep apnea contributes not only to sleepiness and related accidents, but to high blood pressure, heart disease, and many other medical conditions.”
Some experts say any help is welcome.
“This is a huge deal,” Lauri Leadley, a clinical sleep educator and president of Valley Sleep Center in Glendale, Arizona, told Healthline. “Hypoglossal nerve stimulation is the newest, greatest innovation in sleep medicine. Sleep apnea is not a benign illness. It’s the cause of heart attacks, stroke diabetes, weight gain, and may other illnesses.”
Dr. Steven Feinsilver, the director of the Center for Sleep Medicine at Lenox Hill Hospital in New York City, told Healthline the device could be significant if it indeed helps with sleep apnea.
“Snoring is not a disease. It’s a nuisance,” Feinsilver said. “Almost everyone with apnea is a significant snorer — depending on who’s listening — but 90 percent of snorers do not have significant sleep apnea.”
Feinsilver said any advances bringing better sleep are needed.
“We are much better at both diagnosing and treating sleep apnea than we were 20 years ago, and we are also more aware of its complications,” Feinsilver said. “The prevalence of the disease is also likely increasing as the population becomes older and more obese, both of which are risk factors. Still, the majority of people with sleep apnea are neither diagnosed nor treated.”
The FDA said users should have a dental exam before using the device, which isn’t recommended for people with pacemakers or implanted electrodes, temporary or permanent implants, dental braces, intraoral metal prosthesis, restorations/appliances, or dental jewelry in the mouth.
It’s also not recommended for pregnant women or anyone with ulcerations around the mouth. It also shouldn’t be used for sleep apnea patients with an Apnea-Hypopnea Index of 15 and higher.