Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx
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|ClinicalTrials.gov Identifier: NCT03986671|
Recruitment Status : Completed
First Posted : June 14, 2019
Results First Posted : June 21, 2022
Last Update Posted : June 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Amyotrophic Lateral Sclerosis Muscular Dystrophies Healthy||Device: Transmembrane EMG Oropharynx Probe||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a prospective, cohort, pilot study with blinded data analysis and two physician testers to assess intertester reliability and device usability. Volunteers will include healthy adults, participants with documented neurologic pharyngeal muscle dysfunction (ALS and muscular dystrophy), and participants with severe OSA. For each participant diagnostic properties of EMG studies will be assessed using a conventional needle and TM-EMG sensor in pharyngeal muscles.|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Assess Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx|
|Actual Study Start Date :||April 30, 2019|
|Actual Primary Completion Date :||March 26, 2021|
|Actual Study Completion Date :||March 26, 2021|
Experimental: EMG Testing
Examination of the electromyographic signal from oropharyngeal muscles obtained using an investigational transmenbrane sensor attached to a rigid probe and an FDA-approved very fine concentric needle electrode (Ambu Neuroline 25 mm x 30G).
Device: Transmembrane EMG Oropharynx Probe
Examination of the electromyographic signal from oropharyngeal muscles obtained using an investigational transmembrane sensor attached to a rigid probe and an FDA-approved very fine concentric needle electrode (Ambu Neuroline 25 mm x 30G).
- Proof of Diagnostic Consistency [ Time Frame: 1 hour ]Proof of diagnostic consistency using both the TM-EMG sensor and NEMG in neuromuscular disorders of the oropharyngeal muscles. Significant Inter rater reliability between two blinded neuromuscular experts when using TM-EMG in the palatoglossal and genioglossus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986671
|United States, California|
|San Diego, California, United States, 92108|
|Principal Investigator:||Perry Mansfield, MD||Perry Mansfield MD Inc.|