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. The prevalence of OSA increases with age, and if untreated increases the risk of cardiac mortality as well as several comorbidities. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool will allow greater screening of at-risk individuals, enabling a greater proportion of such individuals to seek treatment for their condition. The widespread availability of this device through drugstores and consumer health outlets will additionally allow underprivileged communities access to a high-quality screening tool for sleep apnea. Zansors has developed a bioengineered, semiconductor device that measures breathing and movement during sleep. It is a 1.5 x 1.5 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. The product is 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 risk status. The product features include home-based, easy-to-use, non-invasive, wireless, disposable, and low cost at less than $75, with easily understandable test results. A Phase I STTR award demonstrated that that this device can successfully screen for OSA in adults, with over 70% sensitivity and specificity against gold- standard polysomnography data. In this Phase II project, we will 1) implement Good Manufacturing Practice and quality systems control (ISO 13485); 2)develop and implement novel algorithms to detect hypopneas from sound and motion data ; 3)develop a wireless Bluetooth app that takes the wireless data from the wearable sensor and provides data visualizations on mobile devices ; and 4) validate our data and findings against home sleep testing and polysomnography in a clinical study at the University of Michigan Sleep Disorders Center. 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.
In this Phase II STTR, Zansors in collaboration with University of Michigan Sleep Disorders Center will develop a wireless device for the early screening of sleep apnea at home. Current methods include diagnostic boxes and polysomnography (PSG), which are bulky, cumbersome and expensive ($400-$5,000). Widespread availability of our innovative, FDA-approved, over-the-counter, affordable (<$75), easy-to-use sleep apnea screening device through drugstores, online storefront, and consumer health outlets allows easier access to consumers and reduces health disparities.