Phase II Amount
$1,491,585
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.
Public Health Relevance Statement: PROJECT NARRATIVE 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.
Project Terms: Accelerometer; Adhesives; Adoption; Adult; Affect; Age; Algorithmic Software; Algorithms; Apnea; Apple; Area; Award; Awareness; base; Biomedical Engineering; Boxing; Breathing; Cardiac; Caring; Characteristics; Child; Clinical; Clinical Research; Collaborations; Color; Communication; Communities; Comorbidity; Companions; cost; dashboard; Data; data visualization; Databases; design; Detection; Devices; Diagnostic; Elderly; Electronic Health Record; encryption; Engineering; Event; evidence base; experience; Fatigue; FDA approved; Goals; Gold; Grant; handheld mobile device; Health; health disparity; Health Insurance Portability and Accountability Act; Home environment; Human Engineering; indexing; Individual; innovation; Knowledge; Laboratories; low socioeconomic status; Marketing; Measures; meetings; Mental Depression; Methods; mHealth; Michigan; Microprocessor; mobile application; mortality; Motion; Movement; novel; Obstructive Sleep Apnea; Patients; Penetration; Performance; Phase; Polysomnography; Population; Prevalence; Privacy; Reporting; Research; Risk; Sales; screening; Security; Semiconductors; Sensitivity and Specificity; sensor; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Small Business Innovation Research Grant; Small Business Technology Transfer Research; sound; System; technological innovation; Technology; Telemedicine; Test Result; Testing; tool; Underserved Population; United States National Institutes of Health; Universities; Visual; Wireless Technology
