N/A N=50 Diagnostic

Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx

Obstructive Sleep Apnea · Amyotrophic Lateral Sclerosis · Muscular Dystrophies · Healthy

Bottom Line

View on ClinicalTrials.gov: NCT03986671 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Proof of Diagnostic Consistency — 95.7; 78.1; 90 % agreement

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transmembrane EMG Oropharynx Probe (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Powell Mansfield Inc.
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Proof of Diagnostic Consistency	95.7; 78.1; 90	—

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.

Eligibility Criteria

Inclusion Criteria

Age: 18-70
Must be able to pause use of anticoagulation, NSAID and multi-vitamins for appropriate period prior to study test.
Must be willing to stop any type of smoking or vaping 10 days prior to testing

A cohort of participants with documented neurological disorders involving upper airway striated muscles including ALS and muscular dystrophy with the presence of bulbar symptoms.

A cohort of participants diagnosed with moderate to severe OSA proven by an in-lab PSG, including the following criteria:

AHI > 25
Nadir SaO2 < 85%
not currently using CPAP

A cohort of healthy participants that meet the following criteria:

Normal craniofacial anatomy
BMI < 30

Exclusion Criteria

Allergy to topical anesthetic
4 or more alcoholic drinks on the same occasion on 5 or more days in the past month
Prior cancer, or radiation to the head or neck
Craniofacial anatomical disorders
Presence of any underlying medical, surgical or psychiatric disorder that would preclude participation as determined by the principal investigator

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03986671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.