FDA clears Resonea iPhone app for tackling sleep apnoea
August 6, 2019
The US FDA has given 510(k) clearance to an app from Arizona-based Resonea that turns an Apple iPhone into a medical device for in-home screening of obstructive sleep apnoea (OSA).
Resonea is a technology company founded to create a standard for understanding sleep and breathing and their long-term impact on wellness, performance and quality of life. It has obtained from the US Food & Drug Administration (FDA) clearance for its Drowzle sleep apnoea pre-screening device.
Drowzle is a prescription, Class II medical device that consists of stand-alone smartphone-based software operating on Apple iPhone 7, 8 or X models using iOS v10.0 or later. It records and analyses respiratory patterns during sleep for the purpose of in-home screening for OSA.
Results are used to assist healthcare professionals in determining the need for additional diagnosis and evaluation. Upon commercialisation, the FDA-cleared Drowzle device will be branded to differentiate it from the current consumer-oriented Drowzle sleep health platform.
The software collects symptom data for sleep apnoea risk, including severity of daytime sleepiness and personal chronic disease risk factors. It also records sleep breathing patterns and sends the sound files to secure servers in the cloud for proprietary algorithms to analyse 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 app 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," said Ruchir Sehra, CEO and co-founder of Resonea. "While consumer awareness about sleep apnoea 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."
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 apnoea risk questionnaires reinforces the effectiveness by further reducing the potential for false negative results.
"What's unique about Drowzle is that it can perform in-home screening without any sensors attached to the body,” said Karen Underwood, chief medical officer and co-founder of the company. “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."