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High Adherence Ergonomic Oral Positive Airway Pressure Device

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL082024-01A1
Agency Tracking Number: HL082024
Amount: $103,403.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2006
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
OPAP, INC. 3523 DEANES LANE
CAPITOLA, CA 95101
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 WILLIAM HART
 (831) 458-5626
 hartwi@sutterhealth.org
Business Contact
 CESAR BANDERA
Phone: (831) 458-5626
Email: BANDERA@IEEE.ORG
Research Institution
 RUTGERS THE STATE UNIV OF NJ NEWARK
 
RUTGERS THE STATE UNIVERSITY OF NJ NEWARK 249 UNIVERSITY AVE.
NEWARK, NJ 07102
United States

 Nonprofit College or University
Abstract

DESCRIPTION (provided by applicant): Development of a miniature orally inserted blower with embedded sensing for the diagnosis and treatment of sleep disordered breathing is proposed. This Oral Positive Airway Pressure (OPAP) device represents a potentially radical change in the interface, machine, and patient adherence of sleep disordered breathing treatment. The ergonomic design of the device will facilitate oral and nasal breathing during sleep, eliminate external machines and tubing, and will be retained in the oral cavity during sleep. Inter-individual differences in airway response to sleep disordered breathing will be automatically accounted for by innovative real-time sensing of airway collapse and by the closed-loop coupling between respiratory effort and machine delivery. Ease of use and improved adherence to therapy is anticipated. This research will utilize monitoring technology embedded in the device to objectively document adherence. Information obtained will determine how the nightly duration of use and long term adherence to OPAP can affect morbidity, mortality, healthcare utilization, and quality of life issues. Phase I of this project investigates the feasibility of several candidate OPAP device designs, and evaluates their therapeutic (including air blowing and ergonomics) and diagnostic capacities in airway simulation models and oral cast models. Phase II of the project will obtain clinical trial data of this device and sensor in a clinical trial of sleep disordered breathing patients with the subsequent intention to market and sell this product. Phase II research will also support the investigation of cardiovascular outcomes for those adherent and non-adherent to OPAP treatment for OSA.

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

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