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A Pilot Study to Assess Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx
This is a pilot study to examine the diagnostic utility of a novel transmembrane surface sensor, and compare signals obtained with the transmembrane sensor to conventional needle EMG signals from healthy volunteers to those with documented neurologic pharyngeal muscle dysfunction (ALS and muscular dystrophy) and to those with severe OSA.
Transmembrane electromyography (TM-EMG) may be a feasible and valid non-invasive EMG technique for detecting neuromuscular (NM) impairment. This study will assess whether, in healthy volunteers and participants with known obstructive sleep apnea (OSA) and other NM diseases involving the oropharynx, the same characteristic motor unit potentials obtained on conventional needle EMG (NEMG) can be obtained using a TM-EMG sensor. The purpose of this study is to demonstrate whether the TM-EMG sensor can provide the same diagnostic accuracy as the concentric needle electrode for the diagnosis of NM diseases. Having demonstrated diagnostic similarity of TM-EMG to NEMG, the secondary aim of this study is to confirm that NM disturbance of oropharyngeal striated muscles in participants with OSA can be elicited with the TM-EMG sensor.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
Yes
SENTA Clinic
San Diego, California, United States
Start Date
April 30, 2019
Primary Completion Date
March 26, 2021
Completion Date
March 26, 2021
Last Updated
June 21, 2022
50
ACTUAL participants
Transmembrane EMG Oropharynx Probe
DEVICE
Lead Sponsor
Powell Mansfield Inc.
NCT06430957
NCT07292922
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT01568658