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

Sponsor:

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.

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

Locations

SENTA Clinic, San Diego, California, United States, 92108