RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-24
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06944782

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 years or older
  2. 2. Subject must have completed a prior sleep test.
  3. 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.
  4. 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.
  1. 1. Current use of OSA therapy, including PAP (positive airway pressure) or non-invasive ventilation on a daily basis
  2. 2. Prior uvulopalatopharyngoplasty surgery for sleep apnea.
  3. 3. Inability to install WatchPAT ONE application on smartphone or tablet or unwillingness/inability to use the WatchPAT ONE home sleep study device
  4. 4. Prisoners are excluded due to ethical, legal, and practical concerns
  5. 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. 6. Inability to stop tobacco, marijuana, or vaping on the day of testing.
  7. 7. Binge alcohol use behaviors (4+ drinks on the same occasion on 5+ days in the past month).
  8. 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. 9. Allergy to benzocaine topical anesthetic or other ester class local anesthetics (lidocaine, etc.)
  10. 10. Current psychiatric illness other than treated mood disorders
  11. 11. Unable or unwilling to provide informed consent or comply with research procedures
  12. 12. Active Cancer due to potential interference with study results
  13. 13. Major comorbidities which in the judgment of the investigators could impact the safety or results of the study
  14. 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.

Contacts and Locations

Study Contact

Sleep Research Coordinator
CONTACT
858-246-2154
sleepresearch@health.ucsd.edu

Principal Investigator

Jejo Koola, MD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

University of California San Diego
San Diego, California, 92037
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Jejo Koola, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-24
Study Completion Date2025-09

Study Record Updates

Study Start Date2025-03-24
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • sleep study
  • polysomnography

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea (OSA)
  • OSA
  • Healthy Volunteers
  • Electromyography