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

NCT06944782 | Recruiting DMC

• 2 other identifiers: 315616-00001R42HL176325-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

sleep study; polysomnography

Outcome Measures

Primary Outcomes (1)

• AUC (Area Under the Curve)

  Diagnostic accuracy, as measured by the area under the receiver operator characteristic curve (AUC), of DL-tmEMG algorithm in detecting moderate to severe OSA.

  3 months

Secondary Outcomes (1)

• Delta AUC When Adding Clinical Data

  3 months

Study Arms (2)

Healthy Controls

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

Diagnostic Test: Electromyography (EMG) of the Oropharynx

People with Sleep Apnea

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

Diagnostic Test: Electromyography (EMG) of the Oropharynx

Interventions

Electromyography (EMG) of the Oropharynx DIAGNOSTIC_TEST

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.

Also known as: transmembranous EMG, tmEMG

Healthy Controls; People with Sleep Apnea

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects will be recruited from adult patients who have undergone a sleep study, generally within San Diego County.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Powell Mansfield Inc.: collaborator

Study Sites (1)

University of California San Diego

San Diego, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electrodiagnosis; Diagnostic Techniques and Procedures; Diagnosis; Myography

Study Officials

• Jejo Koola, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sleep Research Coordinator

CONTACT

858-246-2154; sleepresearch@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 25, 2025
• Study Start: March 24, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)