SBIR Phase I: Non-invasive Closed Loop Neuromodulation to Treat Obstructive Sleep Apnea

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a non-invasive, externally worn appliance for treating obstructive sleep apnea (OSA), a condition affecting over 88 million Americans (26% of the American adult population). Those impacted by OSA are at risk of serious comorbidities such as diabetes, stroke, and heart disease. Many sufferers remain untreated due to intolerance to current treatment options with adherence and compliance rates as low as 40%. The economic impact is estimated at $30 billion resulting in $150 billion aggregate indirect costs due to motor and workplace accidents as well as productivity losses each year. The technology aims to capture part of the $18 billion sleep device market which remains significantly under penetrated due to approximately 80 million undiagnosed cases in the US alone. This Small Business Innovation Research (SBIR) Phase I project aims to develop a non-invasive, dental neurostimulation device capable of activating the motor nerve fibers supplying the muscles responsible for dilating the upper airway in a controlled, non-perceptible manner. The appliance will be integrated with multiple sensing and stimulation electrodes to activate precise nerve branches in order to provide continuous innervation of relevant upper airway muscle groups, without interfacing directly with the nerve branch itself. Algorithms employing machine learning will be used to process neural electrode feedback signals and control electrical field stimulation waveforms. The project will consist of appliance design, benchtop testing, and overnight sleep studies in patients to build datasets and construct new algorithms. A software application will then be developed to automate routines in real-time in order to demonstrate concept feasibility of a new non-invasive therapy for obstructive sleep apnea. 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.