Clinical trial NCT03986671: Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx
Official title: A Pilot Study to Assess Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Amyotrophic Lateral Sclerosis
Muscular Dystrophies
Healthy
Lead sponsor: Powell Mansfield Inc.
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Proof of Diagnostic Consistency
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: SENTA Clinic
state: California
Study officials:
affiliation: Perry Mansfield MD Inc.
name: Perry Mansfield, MD
role: PRINCIPAL_INVESTIGATOR
References: