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.
In this Phase I STTR, Zansors in collaboration with University of Michigan Sleep Disorders Center will develop an affordable, wearable sensor from semiconductor and algorithm technologies to better screen sleep apnea for populations facing health disparities. Sleep apnea is a disease that not only has documented co-morbidities such as hypertension, diabetes, and obesity but sleep apnea prevalence rates are high among those in lower social economic status who many times do not have access to affordable medical devices and care. The clinical benefit from this sleep apnea screening test is that patients can determine if they have the symptoms of sleep apnea and thereby seek medical evaluation in addition to closing the gap of health disparities.