CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Transmembrane EMG Oropharynx Probedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03986671
NCT03986671N/ACompleted
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A Pilot Study to Assess Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx

Powell Mansfield Inc.·interventional·Posted Jun 14, 2019·Updated Jun 21, 2022

In Brief

A clinical study evaluating Transmembrane EMG Oropharynx Probe for Obstructive Sleep Apnea and 3 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea, Amyotrophic Lateral Sclerosis, Muscular Dystrophies, Healthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 14, 2019
Enrollment StartApr 30, 2019
Primary CompletionMar 26, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.0 years ago

Interventions

Transmembrane EMG Oropharynx Probedevice

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).