Study Purpose: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.
Obstructive Sleep Apnea , Amyotrophic Lateral Sclerosis , Muscular Dystrophies , Healthy
Type of Intervention:
Transmembrane EMG Oropharynx Probe
Study Chair(s)/Principal Investigator(s):
Perry Mansfield, MD, Perry Mansfield MD Inc.
Coordinating Center Contact Information
San Diego, California, 92108 United States
Full Study Summary:
Powell Mansfield Inc.
Estimated Study Start Date:
04 / 30 / 2019
Estimated Study Completion Date:
03 / 26 / 2021
Posting Last Modified Date:
06 / 21 / 2022
Date Study Added to neals.org:
06 / 14 / 2019
70 YearsInclusion 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
- 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
San Diego, California