Smartphone-Based Obstructive Sleep Apnea Screening Device Gets FDA OK

Ruchir Sehra, MD, ceo, resonea

Ruchir Sehra, MD

The FDA has granted 510(k) clearance to Resonea’s Drowzle Sleep Apnea Pre-screening Device, a prescription Class II medical device that consists of stand-alone smartphone-based software that records and analyzes respiratory patterns during sleep for the purpose of in-home screening for obstructive sleep apnea.

Drowzle’s software collects data for sleep apnea risk including severity of daytime sleepiness and personal chronic disease risk factors. The results are used to assist healthcare professionals in determining the need for additional diagnosis and evaluation. The device records sleep breathing patterns, which are analyzed by proprietary algorithms in the cloud. In addition to the user’s profile, this data helps providers measure and monitor sleep disorder health risks over time. Reports are generated and provided to the individual and healthcare provider via the application and email.

“Sleep breathing disorders are common, costly, dangerous and often worsen other health conditions, such as diabetes, heart disease, obesity and depression,” Ruchir Sehra, MD, chief executive officer and co-founder of Resonea, said in a statement. “While consumer awareness about sleep apnea has increased, most patients with obstructive sleep apnea still do not know they have the disease. Our society has not made adequate progress helping people to understand their risk for obstructive sleep apnea or motivating those at risk to seek appropriate care. The clearance of the Drowzle technology makes in-home screening of adults with possible sleep breathing disorders much easier.”

In a study that included 242 individuals undergoing clinically indicated polysomnography in sleep labs with sleep breathing data simultaneously collected through smartphones, study investigators compared Drowzle’s algorithm to the polysomnography results. The algorithm provided a 93.7% sensitivity scale in the detection of moderate and severe obstructive sleep apnea.

The addition of validated sleep apnea risk questionnaires reinforces the effectiveness of Drowzle’s algorithm potential for false negative results.

According to Resonea, upon commercialization, the device will be branded as a separately-servicing therapy from its current consumer-oriented Drowzle Sleep Health platform.

REFERENCE

RESONEA Obtains FDA Clearance for Smartphone-Based In-Home Screening for Obstructive Sleep Apnea [news release]. Scottsdale, Ariz.: Resonea, Inc., July 25, 2019. https://markets.businessinsider.com/news/stocks/resonea-obtains-fda-clearance-for-smartphone-based-in-home-screening-for-obstructive-sleep-apnea-1028385546. Accessed July 25, 2019.