Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT03589846

Muscle Stimulation During DISE

Drug-induced sleep endoscopy (DISE) is a widely used tool for assessing collapse patterns of the upper airway anatomy during sleep. Hypoglossal nerve stimulation therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. We propose a study examining the physiologic effect of palatoglossus and genioglossus muscle stimulation during DISE.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashvile, Tennessee, 37232, United States

About this study

This is a single-arm study involving the use of a diagnostic device (muscle stimulator) that is not currently utilized in any clinical decision-making processes for OSA patients. All patients scheduled for DISE as part of their regular clinical care will be screened for enrollment via the previously described inclusion and exclusion criteria. The study is not blinded. No diagnostic information collected from muscle stimulation will be used in clinical decision-making processes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient (≥18 years old)
  • A diagnosis of obstructive sleep apnea as determined by polysomnogram with an apnea-hypopnea index of ≥ 5.0/hr.
  • Intolerant of CPAP therapy due to physical or psychosocial limitations as determined by clinical history
  • Scheduled to undergo DISE as part of routine clinical assessment for further evaluation of pharyngeal anatomy

Exclusion criteria

  • Unable to consent for research due to a pre-existing neurologic condition as determined by PI
  • Unable to consent for research due to language barriers
  • A history of egg allergy as determined by history or self-reports
  • Currently pregnant as determined by patient report or pre-operative anesthesia evaluation
  • Cardiopulmonary or other medical conditions precluding safe propofol sedation as determined by pre-operative anesthesia evaluation
  • History of palatal or pharyngeal airway surgery including tonsillectomy as determined by clinical history and exam
  • History of radiation treatment to the head or neck as determined by history and/or physical exam

Treatment and study plan

Grass S88 Muscle Stimulator

Device

The Grass S88 nerve and muscle stimulator is a widely-used tool in electromyography and nerve conduction studies. Under anesthesia, fine-wire electrodes will be placed into the right genioglossus muscle (in the floor of the mouth) and the right palatoglossus muscle (in the anterior tonsillar pillar).

Primary outcomes

  1. Basic physiologic measurements

    Time frame: Collected during operative procedure, taking about 15 minutes.

    This study involves the collection of basic physiologic measurements (airway cross-sectional diameter with and without muscle stimulation) during a single session of DISE.

Secondary outcomes

  1. Amount of current needed for adequate stimulation

    Time frame: Collected during operative procedure, taking about 15 minutes.

    Obtain preliminary data regarding including the amount of current needed to adequately stimulate the palatoglossus muscle.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

The Effect of Palatoglossus and Genioglossus Stimulation During Drug-Induced Sleep Endoscopy

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Jul 18, 2018
Registry last updated
Jan 12, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.