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

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06944782
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Electromyography (EMG) of the Oropharynx — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Mar 24, 2025
Status verified
Apr 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Healthy Controls
    Adults who have completed a sleep study but were not diagnosed with sleep apnea.
  • Arm: People with Sleep Apnea
    Adults who have completed a sleep study and were diagnosed with sleep apnea.

Primary Outcome Measure

AUC (Area Under the Curve) [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoSan DiegoCalifornia92037
Sleep Research Coordinator
[email protected]
858-246-2154

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By research site
University of California San Diego· San Diego, CA

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