Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06944782

Conditions

Obstructive Sleep Apnea (OSA)

OSA

Healthy Volunteers

Electromyography

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Electromyography (EMG) of the Oropharynx

Study Details

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 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

Study ID

NCT06944782

Start date

Mar 24, 2025

Status verified date

Apr, 2025

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Controls

Adults who have completed a sleep study but were not diagnosed with sleep apnea.

People with Sleep Apnea

Adults who have completed a sleep study and were diagnosed with sleep apnea.

Interventions

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.

Primary outcome measure

  • AUC (Area Under the Curve) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

University of California San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

More Information

Sponsor

University of California, San Diego

Last update posted

Apr 25, 2025

Last verified

Apr, 2025

Keywords

  • sleep study
  • polysomnography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-04-25.