Non-Contact Point of Care Device for Sleep Studies

Project Summary/Abstract Proposed is an easy-to-use, non-contact, wearable-free, portable method for the diagnosis of obstructive sleep apnea (OSA) with heart rate, breath rate, and sleep stage monitoring for use in clinical or home settings. Such a system has the potential to also be used for longitudinal monitoring of sleep during interventions. In this Phase IIB effort, the team will complete the evaluation and testing required to bring this product to market. The work also responds to the Notice of Special Interest (NOSI), “Validation of Digital Health and Artificial Intelligence/Machine Learning Tools for Improved Assessment in Biomedical and Behavioral Research.” Significance: An estimated 54 million Americans have sleep apnea, and recent epidemiological studies indicate the prevalence of this disorder is on the rise. OSA is associated with several negative health outcomes including depression and type 2 diabetes. Currently, polysomnography (PSG) is the gold standard test for diagnosis of OSA. PSG systems are complex. They typically require a skilled technician for setup and continuous monitoring to ensure the accuracy of results thereby limiting their use to sleep clinics. However, recent reviews of access to sleep clinics have found supply of OSA diagnostic services is not always able to meet demand. Home sleep apnea test (HSAT) systems do exist, however, like current PSG systems, they employ sensing modalities that suffer from issues of miscalibration or diminished efficacy as the user moves through the night. Sensors typically used by HSAT systems (nose-worn cannula, EEG, plethysmography belts, etc.) must be in direct contact with the patient and are wired to a central recorder that the patient must wear. Patients report that worn/wired sensors are uncomfortable and, in some cases, affect their sleep quality. These issues present a barrier to effective diagnosis of OSA for many populations including the un/under-insured, rural populations, individuals with accessibility needs, those with developmental disabilities, and children. Hypothesis: It is hypothesized that an easy-to-use wearable-free device capable of sensing standard measures of sleep apnea severity (AHI), heart rate, respiratory rate, and sleep stages will make diagnosis available to several populations underserved by current PSG and HSAT technology, thereby increasing the quality of life for those individuals affected by OSA and other conditions. Specific Aims: In the Phase II effort, the proposed sensing technology was demonstrated to be exceptionally effective. In Phase IIB, the following aims are proposed: 1) Finalize technology integration, manufacturing, and test product for commercial readiness, 2) Conduct human subject trial to assess device accuracy compared to gold-standard truth source.