High Adherence Ergonomic Oral Positive Airway Pressure Device

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.