Research Project
8723589
DESCRIPTION (provided by applicant): Obstructive sleep apnea (OSA) is the most common type of sleep apnea. OSA affects an estimated 18-40 million adults and 0.7-3% of all children in the US. OSA results in tiredness, depression and fatigue, and has several associated common comorbidities. It is believed that over 80% of OSA remains undiagnosed. Poorer and disadvantaged communities are at higher risk for sleep disorders, including OSA, even after accounting for other risk factors. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool will allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. The widespread availability of an approved over-the-counter, affordable, easy-to-use sleep apnea screening device through drugstores and consumer health outlets will allow underprivileged communities access to a high-quality screening tool for sleep apnea. Zansors has developed a bioengineered, semiconductor prototype that measures breathing and movement during sleep. It is a 1.5 x 2.5 x 0.2 inch wireless package using four key technologies: (a) an adjustable microphone; (b) a 3-axis accelerometer; (c) embedded algorithms to measure sleep events; and (d) acrylic adhesive. A Phase I STTR grant will demonstrate feasibility of the functional device and preliminary performance from a pilot study. The product will be designed as a FDA-approved over-the-counter device that the patient can wear during sleep and wake up with a color score of red, yellow, or green depending on their sleep apnea status. The product features include home based easy to use, non-invasive, wireless, disposable, and low cost at about $20-50 and presents easily understandable test results. In the Phase II, we will 1) develop a wireless Bluetooth app that takes the wireless data from the wearable sensor and provides data visualizations on mobile devices; 2) perform validation clinical studies at the University of Michigan. The worldwide OSA market will reach $8.4 billion by 2018. The marketplace currently does not have an affordable, easy-to-use over- the-counter home-based OSA screening device. Increasing awareness of OSA and its impact, and a strong unmet need in underserved populations favor market penetration. Partnerships with larger leading sleep treatment companies will help the sales and distribution of the Zansors product.
