Actively Recruiting
Diagnosing Obstructive Sleep Apnea Using Electromyography of the Muscles of the Mouth
Led by University of California, San Diego · Updated on 2025-04-25
60
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Diagnosing Obstructive Sleep Apnea Using Electromyography of the Muscles of the Mouth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Completed a prior sleep test
- Prior sleep test showed either no sleep apnea (AHI < 5) or moderate to severe sleep apnea (AHI ≥ 15)
- Prior sleep test result must be verified by a 2-night home sleep test with consistent findings
You will not qualify if you...
- Currently using sleep apnea therapy such as positive airway pressure or non-invasive ventilation daily
- Prior uvulopalatopharyngoplasty surgery for sleep apnea
- Unable or unwilling to use the WatchPAT ONE home sleep study device or install its application
- Prisoner status
- Pregnant individuals
- Unable to stop tobacco, marijuana, or vaping on the day of testing
- Binge alcohol use (4+ drinks on the same occasion on 5+ days in the past month)
- Use of medications that may cause central apnea affecting safety or study results
- Allergy to benzocaine or other ester class local anesthetics
- Current psychiatric illness except treated mood disorders
- Unable or unwilling to provide informed consent or comply with procedures
- Active cancer
- Major comorbidities that may affect safety or results
- Unable to provide consent and participate in English
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California San Diego
San Diego, California, United States, 92037
Actively Recruiting
Research Team
S
Sleep Research Coordinator
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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