Muscle Stimulation During DISE

Obstructive Sleep Apnea Clinical Trial

Official title:

The Effect of Palatoglossus and Genioglossus Stimulation During Drug-Induced Sleep Endoscopy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03589846
• Other study ID #: 181078
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 26, 2018
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

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).

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Amount of current needed for adequate stimulation	Obtain preliminary data regarding including the amount of current needed to adequately stimulate the palatoglossus muscle.	Collected during operative procedure, taking about 15 minutes.