Sleep Apnea Identification & Treatment in Dentistry

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44DE016772-02
Agency Tracking Number: DE016772
Amount: $566,307.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Solicitation Year: 2007
Award Year: 2007
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
DUNS: 969842715
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 (760) 720-0099
Business Contact
Phone: (760) 720-0099
Research Institution
DESCRIPTION (provided by applicant): Obstructive Sleep Apnea (OSA), a highly prevalent, under-diagnosed disorder affecting over 18 million Americans, is responsible for more mortality and morbidity than any other sleep disorder. Dentists are increasingly involved with the treatment of OSA with oral appliances, an accepted treatment of OSA for patients with mild to moderate disease severity and for those patients who cannot or will not be treated with Continuous Positive Airway Pressure (CPAP). Advanced Brain Monitoring (ABM) developed and validated the Apnea Risk Evaluation System (ARES), a convenient, cost-effective alternative to laboratory sleep studies to facilitate rapid, cost-effective diagnosis of OSA at home. ARES proved effective during the Phase I study in confirming diagnosis of OSA in a dental setting and in evaluating treatment outcome and assessing titration levels in patients fitted with mandibular-advancing devices (MAD). The primary goals for Phase II will be to: 1) acquire a large database of ARES treatment outcome studies from 100 patients treated with MAD, 2) document treatment efficacy using the Alertness and Memory Profiling (AMP) system, a highly sensitive and objective method for quantifying outcome, 3) develop a system for monitoring and improving MAD titration, and 4) develop a model for predicting treatment success with oral appliances. The result of this effort will be to provide a basis for expanded use of MAD therapy by selecting patients most likely to benefit from this treatment and providing measures to maximize the benefit to those selected. Dentists and dental sleep specialists represent an important access point for identifying patients with undiagnosed OSA. Although many individuals do not routinely visit their primary care physicians, the majority receive routine biannual dental examinations. Dental professionals can therefore play an important role in the identification of patients at-risk for OSA. The ARES provides a cost-effective method for dentists and dental sleep specialists to test patients for OSA and evaluate treatment efficacy. The Phase II project is designed to build upon the success achieved during Phase I in working with the dental community to provide a comprehensive program that be implemented to facilitate early identification and efficacious treatment for patients with loud snoring and OSA.

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

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