ORAL APPLIANCE COMPLIANCE & EFFICACY (ACE) SYSTEM

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$210,951.00
Award Year:
2013
Program:
SBIR
Phase:
Phase I
Contract:
1R43HL120421-01
Award Id:
n/a
Agency Tracking Number:
R43HL120421
Solicitation Year:
2013
Solicitation Topic Code:
NHLBI
Solicitation Number:
PA12-088
Small Business Information
4415 EUCLID AVE, CLEVELAND, OH, 44103
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
557510625
Principal Investigator:
MATTHEW TARLER
(216) 791-6720
mtarler@clevemed.com
Business Contact:
MATTHEW TARLER
(216) 619-5915
MTarler@clevemed.com
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): Obstructive Sleep Apnea (OSA) accounts for millions of people not getting adequate or restful sleep and result in loss of productivity, car accidents, and is recognized as a co-morbidity of COPD and other diseases. Snoring, a typical symptom of OSA is also a disruption to a sleeping partner with potentially similar clinical manifestations as the afflicted person themselves. One of the existing approved medical treatment options for snoring and mild to moderate OSA include oral appliances. Oral appliances offer many advantages over the traditional positive airway pressure (PAP) type of devices, including no noise, less physically annoying (to many), and ease of portability. However, oral appliances also lack the capabilities necessary for monitoring compliance and effectiveness that are needed to fulfill regulatory requirements and conduct population-based effectiveness research. The proposed work will design, develop and prototype a new system that will be incorporated into multiple oral appliances and will specifically monitor compliance and effectiveness. The phase I will successfully design, develop, and prototype a system that can be incorporated into the oral appliances. A phase II will develop and implement extended clinical protocols for testing and evaluating the clinical compliance and effectiveness of various oral appliances. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Oral appliances are becoming a more accepted and utilized treatment for Obstructive Sleep Apnea, however, they lack the capabilities necessary for monitoring compliance and effectiveness that are needed to fulfill regulatory requirements and conduct population-based effectiveness research. This proposed work will design, develop and prototype a new system that will be incorporated into multiple oral appliances and will specifically monitor compliance and effectiveness in a non-obtrusive and without any significant increase in patient burden.

* information listed above is at the time of submission.

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