Muscle Stimulation During DISE

NCT03589846 | Enrolling By Invitation FDA Device

• 1 other identifier: 181078
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Basic physiologic measurements

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

  Collected during operative procedure, taking about 15 minutes.

Secondary Outcomes (1)

• Amount of current needed for adequate stimulation

  Collected during operative procedure, taking about 15 minutes.

Study Arms (1)

Muscle stimulation

EXPERIMENTAL

Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) and the Grass S88 muscle stimulator.

Device: Grass S88 Muscle Stimulator

Interventions

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).

Muscle stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashvile, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• David T. Kent, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Otolaryngology

Model Details: All patients who meet eligiblity will undergo muscle stimulation at the same time as the operative DISE procedure.

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 18, 2018
• Study Start: July 26, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)