BREATH: Breakthrough Research in Electromyography for the Assessment of Sleep-disordered BreaTHing

What this Trial Is About

Researchers are evaluating a new, quick, and painless method called transmembraneous electromyography (tmEMG) to measure muscle activity from the mouth and throat for detecting obstructive sleep apnea (OSA). This study addresses the need for an inexpensive and accurate diagnostic test that can be used easily at the point of care. The research includes an initial phase 1 observational feasibility study followed by a larger phase 2 observational study to assess the performance of deep learning-enhanced tmEMG technology. Participants will undergo testing of four muscles in the mouth and throat using a disposable tmEMG probe that lightly touches the muscle surface to record activity. Recordings are taken during different breathing maneuvers, including shallow and deep inspiration for the palatoglossus muscles and maximal and sub-maximal tongue contractions for the genioglossus muscles. Before muscle testing, participants will complete a 2-night home sleep test to confirm previous sleep study results. Two groups include adults without sleep apnea and adults diagnosed with moderate to severe sleep apnea. During the study, participants will visit the clinic for muscle activity measurements using the tmEMG probe while performing specific maneuvers. Researchers will analyze the recordings using a machine learning model to interpret muscle signals. The primary outcome is the accuracy of the test measured by the area under the curve (AUC) at 3 months. Secondary outcomes include changes in AUC when adding clinical data. The study involves healthy volunteers and people with sleep apnea aged 18 to 80 years, with safety and consent procedures in place throughout the study.

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