FDA expands indication of WatchPAT for sleep apnea diagnosis among adolescents

The FDA has expanded the indication for WatchPAT, a home sleep test diagnostic device for sleep apnea, for use among patients as young as 12 years. The decision follows similar approvals in Japan and Europe, and expands the device’s previous U.S. indication for ages 17 years and older.

The incidence of sleep apnea has increased in recent years, particularly among adolescents, according to Itamar Medical, which develops WatchPAT. The increased prevalence has been attributed to rising obesity rates among teenagers.

“We are excited by the FDA’s decision to approve an expanded age indication for our WatchPAT,” Gilad Glick, CEO of Itamar Medical, in a press release. “This clearance is a testament to the solid scientific foundations of our product, as well as to the increasing demand for its use.”

According to the company, many adolescents with sleep apnea suffer from comorbidities, including ADHD, that do not receive the appropriate treatment as long as the underlying sleep apnea remains undiagnosed. Itamar added that 25% or more of ADHD cases in adolescents can be attributed to untreated sleep apnea.

“The clearance of the WatchPAT for clinical use in adolescents is a welcome addition to the currently limited array of home-based diagnostic technologies for children suspected to suffer from sleep-disordered breathing,” David Gozal, MD, of the University of Chicago and president of the American Thoracic Society, said in a press release. “[WatchPAT] should enable reliable and more timely detection of those patients in need for treatment.”