CLEVELAND MEDICAL DEVICES, INC. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant Obstructive Sleep Apnea OSA is a significant problem that is currently treated with CPAP oral appliances or surgery The new Inspire stimulation system has been clinically tested and shown to significantly improve inspiration in a subpopulation but success or failure and mechanisms of action are determined only after implantation What we propose is to develop a sensor platform for oral lingual activity recording before and during the use of a nerve muscle stimulator starting with the Inspire system The new platform will allow increased analysis of the stimulation induced pressure and estimations of force output This platform will record oral pressure signals and respiration from a set of Inspire patients and then use that data to develop an algorithm to predict oro and nasopharyngeal airway opening response to Inspire stimulation The proposed INFORM platform will also be used to monitor tongue forces directionality and activity through the night and how that motion correlates to apnea or flow limitation During wakefulness we will be able to test for muscle fatigue before implantation in the patient population We believe a commercial INFORM platform and the proposed studies can lead to a strategy for pre implant stratification to improve selection of treatment Furthermore the device will allow for tuning of stimulation parameters and monitoring of tongue functions In further applications we envision utility as bio feedback for target outcomes in exercise rehabilitation compliance and utilization data on patients that are prescribed such exercises and a force measure in patients treated with other therapy directed at apnea prevention PUBLIC HEALTH RELEVANCE Hypoglossal nerve stimulation performed with the Inspire stimulation system has improved obstructive sleep apnea and its symptoms in a population but further recordings are required to improve patient selection and stimulation settings We propose this oral mouthpiece for recording of lingual pressures induced by nerve stimulation allowing for direct recording ofthe effectiveness of Inspire stimulation This mouthpiece will also allow testing of stimulation setings predictions for effectiveness and measurement of adherence to therapy