The U.S. FDA granted de novo authorization for Signifier Medical Technologies LLC’s ExciteOSA, the first treatment for mild obstructive sleep apnea and snoring designed for daytime use. Used for 20 minutes a day, the device improves the function of the tongue muscle to prevent airway obstruction while sleeping. ExciteOSA, previously called Snoozeal, already has a CE mark.

“We are thrilled that this groundbreaking treatment will soon be available in the U.S., offering an entirely unique, simple and comfortable solution that has the potential to improve the lives of millions of people,” said Akhil Tripathi, Signifier’s CEO and co-founder. “Restful sleep is critically important, yet for too many it is out of grasp because they or their partner suffer from a sleep disorder. We look forward to launching this revolutionary new option to select markets in the coming weeks.”

Obstructive sleep apnea (OSA) and snoring affects 26% of American adults between the ages of 30 to 70 years and more than one billion adults around the world. Its prevalence has risen markedly over the last two decades in tandem with the global rise in obesity. Symptoms include restless sleep, snoring, daytime tiredness, impaired alertness, and personality changes.

Caused by repeated collapse of the upper airways during sleep and abrupt but often unrecognized awakenings to restore breathing, OSA increases the risk of diabetes and other metabolic disorders as well as cardiovascular disease, glaucoma, cancer, depression, and stroke, while the associated snoring can strain relationships. Sleepiness associated with the repeated disruption and poor quality of sleep characteristic of OSA accounts for $150 billion annually in lost productivity, workplace accidents, and motor vehicle accidents in the U.S. alone, according to the American Academy of Sleep Medicine.

Currently, treatment includes a variety of nighttime oral appliances for mild-to-moderate OSA and continuous positive airway pressure and bilevel positive airway pressure machines used to keep airways open during sleep for moderate-to-severe cases. Several medications address the daytime sleepiness associated with OSA. Other recommended strategies for alleviating OSA and snoring include weight loss, avoidance of alcohol late in the evening, and sleeping on the side or back.

“Obstructive sleep apnea not only impacts sleep quality, but can have other serious health impacts if untreated. Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” said Malvina Eydelman, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health.

Focus on root cause

Unlike other therapies, ExciteOSA aims to resolve the root cause of mild obstructive sleep apnea. “Mild OSA and snoring are caused by the over-relaxation of the muscles in the throat, causing the tongue to fall back in the mouth, partially blocking the upper airway. The snoring sound is generated by the mouth and throat soft tissue vibration,” Tripathi told BioWorld.

ExciteOSA uses an electrical current to stimulate the tongue and improve its muscle function so that it does not collapse during sleep. Maintaining upper airway patency reduces the frequency of obstructive events and improves the quality of sleep, Tripathi added.

The stimulation is delivered through a mouthpiece that sits around the tongue with two electrodes above the tongue and two below. Mild electrical pulses with rest periods between them stimulate the tongue muscle. Patients use the device for 20 minutes once each day for six weeks, then twice a week thereafter.

The device’s “light touch design” allows it to be used out of the box, with no fitting required. An app manages and tracks therapy sessions and gives the user control over therapy levels. Patients can also set reminders for use and track progress against their goals in the app. The system also provides digital connectivity between the user, bed partner, and health care provider to facilitate virtual setup and improved user experience. Signifier offers a portal for providers to use to monitor ExciteOSA patients.

The device is indicated for adults who average more than five but fewer than 15 hourly pauses in breathing, apneas, plus periods of shallow breathing, hypoapneas, during sleep. Only patients with a body mass index below 35 are eligible for ExciteOSA. The device should not be used by individuals with pacemakers or other implants; dental braces, prostheses or jewelry; patients who are or may be pregnant or those with mouth ulcerations.

The FDA evaluated ExciteOSA based on a study of 115 patients with snoring that included 48 who also had mild sleep apnea. Patients used the device for 20 minutes, once a day for six weeks, then stopped use for two weeks prior to reassessment. The percentage of time patient snoring exceeded 40 decibels declined by more than 20% in 87 of the 115 patients.

Among those with both mild OSA and snoring, use of the device nearly halved the average number of apnea and hypoapnea episodes per hour (the Apnea-Hypopnea Index) in 41 of the 48 patients. Common adverse events included excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging and tight jaw.