BREATH: Breakthrough Research in Electromyography for the Assessment of Sleep-disordered BreaTHing
University of California, San Diego
Summary
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.
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, recordi…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
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, the…
Interventions
- Diagnostic TestElectromyography (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.
Location
- University of California San DiegoSan Diego, California