Muscle Stimulation During DISE

• ClinicalTrials.gov Identifier: NCT03589846
• Recruitment Status: Enrolling by invitation
• First Posted: July 18, 2018
• Last Update Posted: October 29, 2021
• Sponsor: Vanderbilt University Medical Center
• Information provided by (Responsible Party): David Kent, Vanderbilt University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obstructive Sleep Apnea	Device: Grass S88 Muscle Stimulator	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All patients who meet eligiblity will undergo muscle stimulation at the same time as the operative DISE procedure.
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: The Effect of Palatoglossus and Genioglossus Stimulation During Drug-Induced Sleep Endoscopy
• Actual Study Start Date: July 26, 2018
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Muscle stimulation; Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) and the Grass S88 muscle stimulator.	Device: 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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

• Principal Investigator: David T. Kent, MD; Vanderbilt University Medical Center

More Information

• Responsible Party: David Kent, Assistant Professor, Department of Otolaryngology, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03589846
• Other Study ID Numbers: 181078
• First Posted: July 18, 2018
• Last Update Posted: October 29, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

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