SSAMSmart Mask System for Sleep Disorder Detection in Sleep Apnea Patients

This clinical study aims to validate a new system called the Smart Mask V1 System (SSAM) designed to monitor sleep stages and disturbances. The study focuses on patients with sleep-disordered breathing conditions, such as central or obstructive sleep apnea, who require assistance from devices like CPAP or BiPAP. The Smart Mask system is being tested to ensure it provides accurate results that are comparable to traditional manual methods (known as polysomnography) and an existing automated system called EnsoSleep. The research hopes to demonstrate that SSAM can reliably detect different sleep stages and disturbances, potentially offering a more efficient way to monitor sleep quality and improve the management of sleep disorders. Participants in this study will undergo overnight sleep evaluations at one of three specialized sleep centers, where they will wear the Smart Mask along with their prescribed sleep therapy device. During the sleep study, various physiological signals such as brain activity, eye movements, and heart rate will be recorded using a combination of sensors. The Smart Mask will process these signals to determine sleep stages and disturbances, which will then be compared to results from standard manual evaluations. Additionally, the study will collect data to train and validate the Smart Mask's ability to classify sleep patterns, ensuring it meets necessary performance standards. This research will help determine if the Smart Mask can be a reliable tool for diagnosing and managing sleep-related conditions.