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DROWZLE is indicated to record a patient's respiratory pattern during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

DROWZLE is a mobile software used to collect 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. DROWZLE then analyzes and interprets the sleep breathing results, along with the profile data provided by the individual, to measure and track sleep-related health risks over time. DROWZLE is a stand-alone software medical device. It operates on a mobile computing device with an Apple iPhone 7, iPhone 8 or iPhone X using iOS v10.0 or later. Breathing sounds during sleep are recorded using the microphone within the mobile device. The sound file is uploaded to a cloud server for analysis using the results of standard questionnaires and a proprietary algorithm. A report is generated and provided to the individual and/or their healthcare provider. Reports are provided within the mobile application and/or via email.