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

BREATH: Breakthrough Research in Electromyography for the Assessment of Sleep-disordered BreaTHing

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; OSA; Obstructive Sleep Apnea (OSA); Electromyography
• Intervention / Treatment: Diagnostic test: Electromyography (EMG) of the Oropharynx

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 screening activities. After verifying that the results of the home sleep test are concordant with the participant's previously administered clinical sleep study, they will be brought to the study clinic. Participants from both arms will undergo testing of four oropharyngeal muscles: left and right palatoglossus, left and right genioglossus. Using the transmembranous electromyography (tmEMG) probe, recordings will be obtained from each muscle using various provocative maneuvers. For the palatoglossus, recordings will be obtained during normal shallow inspiration as well as deep forceful inspiration. For the genioglossus, recordings will be obtained during maximal voluntary contraction as well sub-maximal voluntary contraction of the tongue against resistance (either the buccal mucosa or the front incisors).

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Sleep Research Coordinator; Phone Number: 858-246-2154; Email: sleepresearch@health.ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Recruiting
      • University Of California San Diego
      • Contact: Sleep Research Coordinator; Phone Number: 858-246-2154; Email: sleepresearch@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Controls; Adults who have completed a sleep study but were not diagnosed with sleep apnea.	Diagnostic test: 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.; Other Names: transmembranous EMG; tmEMG
People with Sleep Apnea; Adults who have completed a sleep study and were diagnosed with sleep apnea.	Diagnostic test: 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.; Other Names: transmembranous EMG; tmEMG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta AUC When Adding Clinical Data	The secondary outcome is to assess the incremental improvement in diagnostic performance, as measured by the change in AUC, when selected clinical variables are incorporated into the tmEMG-based machine learning model. These clinical variables may include demographic characteristics, sleep-related questionnaire scores (e.g., STOP-Bang, Epworth Sleepiness Scale), and relevant medical history. Model performance with and without clinical variables will be compared using appropriate statistical techniques to evaluate the added predictive value.	3 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Powell Mansfield Inc.
• Investigators: Principal Investigator: Jejo Koola, MD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: polysomnography; sleep study
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 315616-00001; R42HL176325-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No