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Wireless sensor and telemedicine to screen for sleep apnea in elderly adults

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42MD008845-02
Agency Tracking Number: R42MD008845
Amount: $1,491,585.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIMHD
Solicitation Number: PA15-270
Timeline
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-08-12
Award End Date (Contract End Date): 2019-03-31
Small Business Information
1616 ANDERSON RD
McLean, VA 22102-1602
United States
DUNS: 962122052
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 JTODD ARNEDT
 (734) 764-1234
 tarnedt@med.umich.edu
Business Contact
 JTODD ARNEDT
Phone: (734) 764-1234
Email: tarnedt@med.umich.edu
Research Institution
 CENTRAL MICHIGAN UNIVERSITY
 
251 FOUST HALL
MOUNT PLEASANT, MI 48859-0001
United States

 Nonprofit College or University
Abstract

ABSTRACT
Obstructive sleep apnea OSA is the most common type of sleep apnea OSA affects an estimated
million adults and of all children in the US OSA results in tiredness depression and fatigue and has
several associated common comorbidities It is believed that over 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 x x inch wireless package using four key technologies
a an adjustable microphone b a 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 $ with easily understandable test results A Phase I STTR award demonstrated that that
this device can successfully screen for OSA in adults with over sensitivity and specificity against gold
standard polysomnography data In this Phase II project we will implement Good Manufacturing Practice
and quality systems control ISO develop and implement novel algorithms to detect hypopneas from
sound and motion data develop a wireless Bluetooth app that takes the wireless data from the wearable
sensor and provides data visualizations on mobile devices and 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 $ billion by 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 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 $ $ Widespread
availability of our innovative FDA approved over the counter affordable andlt $ easy to use sleep apnea
screening device through drugstores online storefront and consumer health outlets allows easier access to
consumers and reduces health disparities

* Information listed above is at the time of submission. *

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