Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx
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ClinicalTrials.gov Identifier: NCT03986671 |
Recruitment Status :
Completed
First Posted : June 14, 2019
Results First Posted : June 21, 2022
Last Update Posted : June 21, 2022
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Condition or disease | Intervention/treatment | Phase |
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Obstructive Sleep Apnea Amyotrophic Lateral Sclerosis Muscular Dystrophies Healthy | Device: Transmembrane EMG Oropharynx Probe | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
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. |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Pilot Study to Assess Transmembrane Electromyography (TM-EMG) for the Assessment of Neuromuscular Function in the Oropharynx |
Actual Study Start Date : | April 30, 2019 |
Actual Primary Completion Date : | March 26, 2021 |
Actual Study Completion Date : | March 26, 2021 |

Arm | Intervention/treatment |
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Experimental: EMG Testing
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).
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Device: Transmembrane EMG Oropharynx Probe
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). |
- 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.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986671
United States, California | |
SENTA Clinic | |
San Diego, California, United States, 92108 |
Principal Investigator: | Perry Mansfield, MD | Perry Mansfield MD Inc. |
Documents provided by Powell Mansfield Inc.:
Responsible Party: | Powell Mansfield Inc. |
ClinicalTrials.gov Identifier: | NCT03986671 |
Other Study ID Numbers: |
TM-EMG Pilot Study |
First Posted: | June 14, 2019 Key Record Dates |
Results First Posted: | June 21, 2022 |
Last Update Posted: | June 21, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
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.: | No |
Muscular Dystrophies Sleep Apnea, Obstructive Motor Neuron Disease Amyotrophic Lateral Sclerosis Sleep Apnea Syndromes Apnea Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |
Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases Genetic Diseases, Inborn |