๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-04-21

Diagnosing Obstructive Sleep Apnea Using Electromyography of the Muscles of the Mouth (NCT06944782)

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

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: University of California, San Diego

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of California San Diego โ€” San Diego, California

Age range: 18 Years to 80 Years

๐Ÿงช Interventions in This Study

  • Electromyography (EMG) of the Oropharynx (DIAGNOSTIC_TEST)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • University of California San Diego โ€” San Diego, California

๐Ÿ“ž Contact the Study Coordinator

Phone: (858) 246-2154

Email: sleepresearch@health.ucsd.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—