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

NCT06944782 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-04-25

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jejo Koola, MD · University of California, San Diego

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-24
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06944782 on ClinicalTrials.gov