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ORAL APPLIANCE COMPLIANCE & EFFICACY (ACE) SYSTEM

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2013 / SBIR
Agency Tracking Number:
R43HL120421
Solicitation Year:
2013
Solicitation Topic Code:
NHLBI
Solicitation Number:
PA12-088
Small Business Information
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE CLEVELAND, OH 44103
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2013
Title: ORAL APPLIANCE COMPLIANCE & EFFICACY (ACE) SYSTEM
Agency: HHS
Contract: 1R43HL120421-01
Award Amount: $210,951.00
 

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.

Principal Investigator:

Matthew D. Tarler
(216) 791-6720
mtarler@clevemed.com

Business Contact:

Matthew Tarler
(216) 619-5915
MTarler@clevemed.com
Small Business Information at Submission:

CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE CLEVELAND, OH 44103

EIN/Tax ID: 134167563
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No