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| ID | Type | Description | Link |
|---|---|---|---|
| R42HL176325-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Powell Mansfield Inc. | OTHER |
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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.
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, recordings will be obtained from each muscle using various provocative maneuvers. For the palatoglossus, recordings will be obtained during normal shallow inspiration as well as deep forceful inspiration. For the genioglossus, recordings will be obtained during maximal voluntary contraction as well sub-maximal voluntary contraction of the tongue against resistance (either the buccal mucosa or the front incisors).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | Adults who have completed a sleep study but were not diagnosed with sleep apnea. |
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| People with Sleep Apnea | Adults who have completed a sleep study and were diagnosed with sleep apnea. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electromyography (EMG) of the Oropharynx | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (Area Under the Curve) | Diagnostic accuracy, as measured by the area under the receiver operator characteristic curve (AUC), of DL-tmEMG algorithm in detecting moderate to severe OSA. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Delta AUC When Adding Clinical Data | The secondary outcome is to assess the incremental improvement in diagnostic performance, as measured by the change in AUC, when selected clinical variables are incorporated into the tmEMG-based machine learning model. These clinical variables may include demographic characteristics, sleep-related questionnaire scores (e.g., STOP-Bang, Epworth Sleepiness Scale), and relevant medical history. Model performance with and without clinical variables will be compared using appropriate statistical techniques to evaluate the added predictive value. |
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Inclusion Criteria:
Age 18 years or older
Subject must have completed a prior sleep test.
Exclusion Criteria:
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Study subjects will be recruited from adult patients who have undergone a sleep study, generally within San Diego County.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sleep Research Coordinator | Contact | 858-246-2154 | sleepresearch@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jejo Koola, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | San Diego | California | 92037 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004576 | Electromyography |
| ID | Term |
|---|---|
| D004568 | Electrodiagnosis |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009213 | Myography |
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| 3 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |