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NCT Number: NCT03986671

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transmembrane EMG Oropharynx Probe

Device

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).

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Powell Mansfield Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2019
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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