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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Electromyography (EMG) of the Oropharynx

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, San Diego

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Powell Mansfield Inc.

Collaborator