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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Apr 21, 2025

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ClinConnect Summary

This clinical trial is studying a new method for diagnosing obstructive sleep apnea (OSA), a condition where a person's breathing is interrupted during sleep. The researchers are testing a quick and painless technique called transmembraneous electromyography (tmEMG), which measures muscle activity in the mouth and throat. By using a special probe that lightly touches these muscles and advanced computer technology to interpret the data, the team hopes to create an inexpensive and accurate way to screen for sleep apnea at the point of care.

To participate in this trial, you need to be at least 18 years old and have completed a previous sleep test that either confirmed or ruled out sleep apnea. Participants cannot currently be using treatments for sleep apnea or have had certain surgeries for the condition. If you join, you will use a home sleep study device and your muscle activity will be recorded to help researchers evaluate the effectiveness of this new testing method. It's important to note that pregnant individuals and those with certain health issues may not be eligible for this study. If you're interested, the team is currently recruiting participants, and they're looking forward to potentially improving how we diagnose sleep apnea.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or older
• • 2. Subject must have completed a prior sleep test.
• • 1. Subjects may be recruited if the last prior sleep test either determined that they do not have sleep apnea OR they have moderate to severe sleep apnea. No sleep apnea is defined by AHI \< 5; moderate to severe sleep apnea is defined by AHI \>= 15.
• • 2. To be fully eligible, the prior test result needs to be verified via 2-night home sleep test (using the average AHI from the 2 nights). If OSA status (i.e., AHI\<5/h or \>=15/h) from the 2-night HST vs last prior sleep test is discordant, then participants will be excluded as screen failures.
• Exclusion Criteria:
• • 1. Current use of OSA therapy, including PAP (positive airway pressure) or non-invasive ventilation on a daily basis
• • 2. Prior uvulopalatopharyngoplasty surgery for sleep apnea.
• • 3. Inability to install WatchPAT ONE application on smartphone or tablet or unwillingness/inability to use the WatchPAT ONE home sleep study device
• • 4. Prisoners are excluded due to ethical, legal, and practical concerns
• • 5. Individuals who are pregnant are excluded due to temporary changes in habitus, fluid shifts, and potential changes to oropharyngeal musculature may impact tmEMG assessment. This important subpopulation will be investigated in a later phase study.
• • 6. Inability to stop tobacco, marijuana, or vaping on the day of testing.
• • 7. Binge alcohol use behaviors (4+ drinks on the same occasion on 5+ days in the past month).
• • 8. Medication use that may cause central apnea that in the judgment of the investigators could impact the safety or results of the study
• • 9. Allergy to benzocaine topical anesthetic or other ester class local anesthetics (lidocaine, etc.)
• • 10. Current psychiatric illness other than treated mood disorders
• • 11. Unable or unwilling to provide informed consent or comply with research procedures
• • 12. Active Cancer due to potential interference with study results
• • 13. Major comorbidities which in the judgment of the investigators could impact the safety or results of the study
• • 14. Inability to sign consent and participate in the study in English. This study involves use of an investigational device; the technical nature of the study and the consenting process and consent form make it impractical to include subjects who cannot participate in English.