Technology company Resonea Inc has obtained 510(k) clearance from the US Food and Drug Administration (FDA) on July 14, 2019 for its DROWZLE Sleep Apnea Pre-screening Device.
DROWZLE is a prescription, Class II medical device that consists of standalone smartphone-based software (operating on Apple iPhone 7, 8, or X model using iOS v10.0 or later) that records and analyzes respiratory patterns during sleep for the purpose of in-home screening for obstructive sleep apnea (OSA). Results are used to assist healthcare professionals in determining the need for additional diagnosis and evaluation. Upon commercialization, the FDA-cleared DROWZLE device will be distinctly branded to differentiate it from the current consumer-oriented DROWZLE Sleep Health platform.
DROWZLE software collects symptom data for sleep apnea risk, including severity of daytime sleepiness and personal chronic disease risk factors. DROWZLE also records sleep breathing patterns and sends the sound files to secure servers in the cloud for proprietary algorithms to analyze the results. Along with the profile data, this helps providers measure and monitor sleep disorder health risks over time. HIPAA-compliant reports are generated and provided to the individual and their healthcare provider via the mobile application and secure, encrypted email.
“Sleep breathing disorders are common, costly, dangerous and often worsen other health conditions, such as diabetes, heart disease, obesity, and depression,” says Ruchir Sehra, MD, CEO and co-founder of Resonea, in a release. “While consumer awareness about sleep apnea has increased, most patients with OSA still do not know they have the disease. Our society has not made adequate progress helping people to understand their risk for OSA 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.”
Karen Underwood, MD, chief medical officer and co-founder of the company, says, “What’s unique about DROWZLE is that it can perform in-home screening without any sensors attached to the body. The ease of use and convenience can reduce key obstacles to getting tested. DROWZLE also delivers educational and motivational content to help spur those who are at risk to see their provider for recommended treatment and follow up. Increased accessibility to screening can result in more people receiving medical care.”
In an IRB-approved study of 242 individuals undergoing clinically indicated polysomnography (PSG) in sleep labs, with sleep breathing data simultaneously collected through smartphones, the DROWZLE algorithm was tested against the PSG results, providing a sensitivity of 93.7% to detect people with moderate and severe OSA. The inclusion of validated sleep apnea risk questionnaires reinforces the effectiveness by further reducing the potential for false negative results.