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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Pilot Study to Assess Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx

Conditions
-----------------
Obstructive Sleep Apnea, Amyotrophic Lateral Sclerosis, Muscular Dystrophies, Healthy

Intervention / Treatment
-----------------
* Device: Transmembrane EMG Oropharynx Probe


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMG Testing<br>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<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proof of Diagnostic Consistency | 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. | 1 hour |