Status:
RECRUITING
Diagnosing Obstructive Sleep Apnea Using Electromyography of the Muscles of the Mouth
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Powell Mansfield Inc.
Conditions:
Obstructive Sleep Apnea (OSA)
OSA
Eligibility:
All Genders
18-80 years
Brief 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 transmembra...
Detailed Description
Given night-to-night variability and/or changes in OSA severity over time, study participants will undergo a 2-night home sleep test to verify the results of a prior sleep test as part of our screenin...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Subject must have completed a prior sleep test.
- 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.
- 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
- Current use of OSA therapy, including PAP (positive airway pressure) or non-invasive ventilation on a daily basis
- Prior uvulopalatopharyngoplasty surgery for sleep apnea.
- Inability to install WatchPAT ONE application on smartphone or tablet or unwillingness/inability to use the WatchPAT ONE home sleep study device
- Prisoners are excluded due to ethical, legal, and practical concerns
- 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.
- Inability to stop tobacco, marijuana, or vaping on the day of testing.
- Binge alcohol use behaviors (4+ drinks on the same occasion on 5+ days in the past month).
- Medication use that may cause central apnea that in the judgment of the investigators could impact the safety or results of the study
- Allergy to benzocaine topical anesthetic or other ester class local anesthetics (lidocaine, etc.)
- Current psychiatric illness other than treated mood disorders
- Unable or unwilling to provide informed consent or comply with research procedures
- Active Cancer due to potential interference with study results
- Major comorbidities which in the judgment of the investigators could impact the safety or results of the study
- 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.
Key Trial Info
Start Date :
March 24 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06944782
Start Date
March 24 2025
End Date
September 1 2025
Last Update
April 25 2025
Active Locations (1)
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1
University of California San Diego
San Diego, California, United States, 92037