FDA Clears Novel Daytime Device For Obstructive Sleep Apnea
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The US Food and Drug Administration (FDA) has approved the first device to help reduce snoring and mild obstructive sleep apnea (OSA) that is used during the day while the patient is awake.

eXciteOSA is a prescription-only, neuromuscular stimulation device designed to improve tongue muscle function, which, over time, can help prevent the tongue from collapsing backwards and obstructing the airway during sleep, the FDA said.

The patient uses the device for 20 minutes once a day while awake for 6 weeks and once a week thereafter. It is indicated for adults aged 18 and older with snoring and mild OSA. OSA is marked by the recurring collapse of the upper airways during sleep. Common symptoms include snoring, restless sleep, and daytime sleepiness.

The FDA reviewed data on the safety and effectiveness of the eXciteOSA device in 115 patients with snoring, including 48 patients with snoring and mild OSA. All patients used the device for 20 minutes once a day for 6 weeks, then stopped using it for 2 weeks before they were reassessed. Overall, the percentage of time spent snoring at levels louder than 40 decibels (dB) was reduced by more than 20% in 87 out of the 115 patients.

In the subset of patients with snoring and mild OSA, the average apnea-hypopnea index (AHI) score was reduced by 48%, from 10.21 to 5.27, in 41 of 48 patients. Mild OSA is defined as an AHI score greater than 5 but less than 15. The most common adverse events were excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging, and tight jaw.

Before using the eXciteOSA device, patients should receive a comprehensive dental examination, the FDA says. The device should not be used in patients with pacemakers or implanted pacing leads, or women who are pregnant. The device is also contraindicated in patients with temporary or permanent implants, dental braces, intraoral metal prosthesis/restorations, or ulcerations in or around the mouth.

Source:
https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-novel-device-reduce-snoring-and-mild-obstructive-sleep-apnea-patients-18
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