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Enrolling by invitationNCT03589846Updated Aug 21, 2026

Muscle Stimulation During DISE

An interventional study of Grass S88 Muscle Stimulator in Obstructive Sleep Apnea, sponsored by Vanderbilt University Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obstructive Sleep Apnea
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceGrass 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).

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Collected during operative procedure, taking about 15 minutes.

Secondary outcomes

  1. Amount of current needed for adequate stimulation

    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.

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Study locations

1 site
  • Vanderbilt University Medical Center
    Nashvile, Tennessee 37232, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03589846
Lead sponsor
Vanderbilt University Medical Center
Responsible party
David Kent (Assistant Professor, Department of Otolaryngology, Vanderbilt University Medical Center) — Principal investigator
First posted
Jul 18, 2018
Start date
Jul 26, 2018
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 21, 2026

Study contacts

David T. Kent, MD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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