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

Primary Purpose

Obstructive Sleep Apnea, Amyotrophic Lateral Sclerosis, Muscular Dystrophies

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transmembrane EMG Oropharynx Probe

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

SENTA Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EMG Testing

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03986671

First Posted

May 22, 2019

Last Updated

June 16, 2022

Sponsor

Powell Mansfield Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03986671

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

April 30, 2019 (Actual)

Primary Completion Date

March 26, 2021 (Actual)

Study Completion Date

March 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Powell Mansfield Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EMG Testing

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Transmembrane EMG Oropharynx Probe

Intervention Description

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 Outcome Measure Information:

Title

Proof of Diagnostic Consistency

Description

Time Frame

1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Perry Mansfield, MD

Organizational Affiliation

Perry Mansfield MD Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

SENTA Clinic

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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