Muscle Stimulation During DISE

Not Applicable

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Grass S88 Muscle Stimulator

• Registration Number: NCT03589846
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-18
• Study Start: 2018-07-26
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Muscle stimulation	Grass S88 Muscle Stimulator	Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) and the Grass S88 muscle stimulator.

Primary Outcome Measures

Name	Time	Method
Basic physiologic measurements	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

Name	Time	Method
Amount of current needed for adequate stimulation	Collected during operative procedure, taking about 15 minutes.	Obtain preliminary data regarding including the amount of current needed to adequately stimulate the palatoglossus muscle.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashvile, Tennessee, United States