NCT06944782

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Given night-to-night variability and/or changes in OSA severity over time, study participants will undergo a 2-night home sleep test to verify the results of a prior sleep test as part of our screening activities. After verifying that the results of the home sleep test are concordant with the participant's previously administered clinical sleep study, they will be brought to the study clinic. Participants from both arms will undergo testing of four oropharyngeal muscles: left and right palatoglossus, left and right genioglossus. Using the transmembranous electromyography (tmEMG) probe, recordings will be obtained from each muscle using various provocative maneuvers. For the palatoglossus, recordings will be obtained during normal shallow inspiration as well as deep forceful inspiration. For the genioglossus, recordings will be obtained during maximal voluntary contraction as well sub-maximal voluntary contraction of the tongue against resistance (either the buccal mucosa or the front incisors).

Conditions

• Obstructive Sleep Apnea (OSA)
• OSA
• Healthy Volunteers
• Electromyography

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Electromyography (EMG) of the Oropharynx	The transmembranous electromyography (tmEMG) probe is a disposable single-use bipolar recording device with the sensor configured with two electrodes located at the distal end of the probe in a parallel orientation. Unlike conventional EMG probes that are designed to be inserted into the muscle, the tmEMG probe is placed on the surface of the muscle similar to a surface electrode; the tip of the probe is approximately the size of a ball point pen, which allows us to record from the smaller muscles inside the mouth. Recordings will be taken from the genioglossus and palatoglossus in the mouth bilaterally. Recordings will be taken while the subject performs various maneuvers such as shallow breathing, deep breathing, and pressing their tongue against the side of their mouth.

Timeline

• Start date: 2025-03-24
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-04-25
• Last updated: 2025-04-25

Locations

1 site across 1 country: United States