Muscle Stimulation During DISE

NCT ID: NCT03589846

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-26
• Study Completion Date: 2028-12-31

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.

Detailed Description

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Muscle stimulation

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

Group Type: EXPERIMENTAL

Grass S88 Muscle Stimulator

Intervention Type: 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).

Interventions

Grass S88 Muscle Stimulator

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adult patient (≥18 years old)

2. A diagnosis of obstructive sleep apnea as determined by polysomnogram with an apnea-hypopnea index of ≥ 5.0/hr.

3. Intolerant of CPAP therapy due to physical or psychosocial limitations as determined by clinical history

4. Scheduled to undergo DISE as part of routine clinical assessment for further evaluation of pharyngeal anatomy

Exclusion Criteria

1. Unable to consent for research due to a pre-existing neurologic condition as determined by PI

2. Unable to consent for research due to language barriers

3. A history of egg allergy as determined by history or self-reports

4. Currently pregnant as determined by patient report or pre-operative anesthesia evaluation

5. Cardiopulmonary or other medical conditions precluding safe propofol sedation as determined by pre-operative anesthesia evaluation

6. History of palatal or pharyngeal airway surgery including tonsillectomy as determined by clinical history and exam

7. History of radiation treatment to the head or neck as determined by history and/or physical exam

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Kent

Assistant Professor, Department of Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David T. Kent, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashvile, Tennessee, United States

Countries

United States

Other Identifiers

181078

Identifier Type: -

Identifier Source: org_study_id