FDA Clears At-Home Sleep Apnea Monitoring Device

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the DROWZLE Sleep Apnea Pre-screening Device from Resonea Inc.

The prescription medical device includes standalone smartphone software that can record and analyze patient respiratory patterns mid-sleep, in order to allow telemonitoring for obstructive sleep apnea (OSA). DROWZLE’s software collects the symptom data to assess for OSA risk, while recording and sharing sleep breathing patterns to secure servers designed to analyze results with proprietary Resonea algorithms.

According to the company, the device will be specifically branded as a separately-servicing therapy from its DROWZLE Sleep Health platform.

In a study including 242 individuals administered a clinically indicated polysomnography (PSG) in sleep lab, investigators compared the DROWZLE algorithm to PSG results. They found the algorithm provided a 93.7% sensitivity scale in the detection of moderate and severe OSA among individuals.

They concluded that, with the addition of validated sleep apnea risk questionnaires, the algorithms’ potential for false negative results is reduced even further.

Ruchir Sehra, MD, chief executive officer and co-founder of Resonea, not that OSA and other sleep breathing disorders have become common, costly, and dangerous conditions—and are frequently associated with worsened comorbidities such as diabetes, cardiovascular disease, and depression. Though public awareness surrounding OSA has increased, most patients are still unaware of their diagnosis.

“Our society has not made adequate progress helping people to understand their risk for OSA or motivating those at risk to seek appropriate care,” Sehra said in a statement. “The clearance of the DROWZLE technology makes in-home screening of adults with possible sleep breathing disorders much easier."