Description:
Summary
As a therapeutic option, an array of existing oral appliances are approved for the medical treatment of snoring and mild to moderate obstructive sleep apnea but lack specific capabilities necessary to fulfill regulatory requirements and conduct population-based effectiveness research. Integration of oral appliance and electronic monitoring technologies is needed to develop enhanced oral devices capable of addressing regulatory requirements and facilitating population-based research and clinical trials monitoring adherence and effectiveness of sleep apnea treatment.
Project Goals
Adapt therapeutic oral appliances currently used to maintain an open airway during sleep with electronic and sensor technologies to quantitatively monitor and evaluate patient adherence and the effectiveness of treatment. Validate the implementation of monitoring technologies as needed to fulfill regulatory requirements. Since oral appliances vary in how an open airway is maintained, it is anticipated that 2-3 different oral appliances with integrated monitoring capability. Proposals to develop an oral appliance treatment as opposed to integrate monitoring capabilities into an existing technology will not be considered responsive to this request.
Phase I Activities and Expected Deliverables
Development of a prototype oral appliance with an integrated capability of monitoring treatment adherence and efficacy up to 24 hours independent of external power sources and connections. The enhanced oral appliance must be should not change acceptance of the device by patients, interfere with therapeutic efficacy of the device, increase patient burden, or introduce potential electrical or biological risks to patient safety over the anticipated life of the instrument. The prototype must demonstrate that the proposed design specifications including sensitivity and longevity of sensor technology have been achieved for successful completion of phase I activities.
Phase II Activities and Expected Deliverables
A sufficient number of working devices and procedures for deployment and field testing must be developed. These procedures should validate the capabilities of the monitoring technology, demonstrate adherence to therapy, and the efficacy of treatment fulfilling regulatory requirements of the commercial transportation industry. Validation includes field testing in a representative cohort of middle-age men and women diagnosed with sleep apnea and physician-recommended treatment using an oral appliance. The cohort must be designed to allow a stratified analysis of the device capabilities among apnea patients with Epworth Sleepiness Scale scores greater than or equal to 10 compared to apnea patients with scores below 10. The results obtained from device monitoring should be compared with correlative measures such as actigraphy, daytime sleepiness and psychomotor vigilance task to establish that the monitoring capabilities of the integrated device can be used to accurately predict functional outcomes. Proposals to enhance standard medical practice in diagnosis or treatment of sleep apnea will not be considered responsive.
