New method for diagnosing obstructive sleep apnea using muscle activity measurements
BREATH: Breakthrough Research in Electromyography for the Assessment of Sleep-disordered BreaTHing
This study is trying out a new, painless way to diagnose obstructive sleep apnea by measuring muscle activity in the mouth and throat to see if it can provide accurate results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06944782 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a novel and painless technique for detecting obstructive sleep apnea (OSA) by measuring muscle activity in the mouth and throat using transmembranous electromyography (tmEMG). Participants will undergo a two-night home sleep test to confirm their OSA status before being tested in a clinic setting. The study will assess the performance of tmEMG combined with machine learning for interpreting muscle activity signals, addressing the need for an accurate and cost-effective diagnostic tool for OSA. The research will involve testing four specific oropharyngeal muscles during various breathing maneuvers to gather data on muscle function related to sleep apnea.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have previously undergone a sleep test confirming their OSA status.
Not a fit: Patients currently using OSA therapy or who have had prior surgery for sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accessible and accurate method for diagnosing obstructive sleep apnea, improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using muscle activity for diagnosing sleep disorders, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Diego, California
- University of California San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Jejo Koola, MD — University of California, San Diego
- Study coordinator: Sleep Research Coordinator
- Email: sleepresearch@health.ucsd.edu
- Phone: 858-246-2154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.