Inspire Feedback Oral Recording Monitor (INFORM)

Cleveland Medical Devices, Inc., Cleveland OH

Investigators

Abstract

? 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.