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Muscle Stimulation During DISE

Primary Purpose

Obstructive Sleep Apnea

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Grass S88 Muscle Stimulator
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Muscle stimulation

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 6, 2018
Last Updated
August 21, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03589846
Brief Title
Muscle Stimulation During DISE
Official Title
The Effect of Palatoglossus and Genioglossus Stimulation During Drug-Induced Sleep Endoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 26, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients who meet eligiblity will undergo muscle stimulation at the same time as the operative DISE procedure.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Muscle stimulation
Arm Type
Experimental
Arm Description
Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) and the Grass S88 muscle stimulator.
Intervention Type
Device
Intervention Name(s)
Grass S88 Muscle Stimulator
Intervention Description
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 Outcome Measure Information:
Title
Basic physiologic measurements
Description
This study involves the collection of basic physiologic measurements (airway cross-sectional diameter with and without muscle stimulation) during a single session of DISE.
Time Frame
Collected during operative procedure, taking about 15 minutes.
Secondary Outcome Measure Information:
Title
Amount of current needed for adequate stimulation
Description
Obtain preliminary data regarding including the amount of current needed to adequately stimulate the palatoglossus muscle.
Time Frame
Collected during operative procedure, taking about 15 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David T. Kent, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Muscle Stimulation During DISE

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