Diagnosing Obstructive Sleep Apnea Using Electromyography of the Muscles of the Mouth

The investigators will establish how well a novel, quick, and painless way of measuring muscle activity from the mouth and throat works for detecting sleep apnea. This technology is called transmembraneous electromyography (tmEMG). Leveraging two technologies, a new probe capable of recording muscle activity by lightly touching the muscle, as well as a machine learning model for signal interpretation, the investigators will conduct an initial observational feasibility study in phase 1, followed by a larger observational cohort study in phase 2 to assess the performance of deep learning enhanced tmEMG. The study will address a critical unmet need in sleep apnea diagnostics: the availability of an inexpensive, accurate diagnostic test for screening at point of care.

NCT Number	NCT06944782
Lead Sponsor	University of California, San Diego Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Powell Mansfield Inc.
Conditions	Obstructive Sleep Apnea (OSA), OSA, Healthy Volunteers, Electromyography
Enrollment	60 participants
Start Date	2025-03-24
Primary Completion	2025-09 (estimated)
Study Completion	2025-09 (estimated)
Updated on ClinicalTrials.gov	2025-04-25