New method for diagnosing obstructive sleep apnea using muscle activity measurements

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PMOS and Sleep Apnea: A Pilot Look at Mitochondrial Function

  In women with PMOS, this pilot study tests whether sleep apnea treatment with CPAP improves mitochondrial function in leg muscle tissue.

  Recruiting University of Chicago · Chicago, Illinois · NCT07871149

• F&P Mask usability in home PAP/NIV care for adults with chronic breathing conditions

  This study tests how well the F&P Licorice Mask works at home for adults who already use PAP or NIV therapy.

  Recruiting Fisher and Paykel Healthcare · St Louis, Missouri · NCT07826429

• Sleep apnea biomarkers and CPAP use after diagnosis

  This study tests whether biomarkers from a diagnostic sleep study can predict how well adults with newly diagnosed obstructive sleep apnea will stick to CPAP therapy after about 3 months.

  Recruiting Clinique du Millenaire · Montpellier · NCT07792746

• Using the PLATO Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea

  This real-world study tests whether the PLATO questionnaire can be feasibly used in dental sleep clinics for patients receiving oral appliance therapy for obstructive sleep apnea.

  Recruiting Nevada Dental Sleep · Henderson, Nevada · NCT07789834

• Managing COMISA: adding daridorexant to CPAP may help sleep and CPAP use

  This study tests whether adding daridorexant to CPAP helps people with COMISA better stick with CPAP and feel better.

  Recruiting University Hospital, Grenoble · Grenoble and 4 other locations · NCT07743931

• OSA Screening in Diverse Populations

  This study tests how common obstructive sleep apnea is across community members and people with certain diseases in China, using screening questionnaires and polysomnography or portable sleep monitors.

  Recruiting Guangzhou Institute of Respiratory Disease · Guangzhou, Guangdong and 1 other locations · NCT07736872

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.