I-Corps: Neurostimulation Platform for Effective Treatment of Palatal Collapse in Obstructive Sleep Apnea

Johns Hopkins University, Baltimore MD

Investigators

Abstract

The broader impact/commercial potential of this I-Corps project is the development of a solution for complete concentric collapse of the palate (CCCp), a severe anatomical phenotype of obstructive sleep apnea (OSA). OSA affects over 1 billion people globally, including 54 million in the U.S. Untreated, CCCp leads to debilitating daytime sleepiness, neurocognitive dysfunction, accidents, and doubles the risk of heart attack, stroke, and diabetes, costing the US healthcare system $88 billion annually. Notably, 30% of all OSA patients, or 16 million Americans, suffer from CCCp, a particularly challenging form of sleep apnea to treat. Over half of the patients fail the first-line treatment of continuous positive airway pressure (CPAP), and many avoid costly surgeries, leaving 6 million untreated yearly. This solution offers a non-invasive, clinically effective treatment for OSA patients, focusing on CCCp and poorly treated palatal collapse. This technology seeks to transform sleep apnea care by providing an accessible treatment option with significant societal and commercial impact. This I-Corps project is based on the development of a neurostimulation platform addressing the need for non-invasive, clinically effective treatment of palatal collapse in obstructive sleep apnea (OSA) patients. Unlike traditional neurostimulation methods with limited applicability and invasive implantation, this approach takes a non-invasive approach by targeting stimulation to the palate and pharynx. The device may be fit and titrated in-clinic and deployed by patients each night at-home. The technology involves a removable oral appliance that activates stimulation during sleep, timing therapy delivery to patient inspiration. The device set, comprising the oral appliance and a wireless charging case, enables easy control of stimulation parameters. The case also records and uploads usage and disease parameters, offering data for clinician-guided therapy optimization. Validation through research, including benchtop, ex-vivo and in-vivo porcine and cadaver studies, has poised this technology for clinical trials and eventual Food and Drug Administration approval. These studies confirm the ability to elicit clinically significant muscle responses using non-invasive neurostimulation, creating a solution that addresses the root cause of collapse in OSA patients. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.