Muscle Stimulation During DISE

Part of paid clinical trials in Nashvile, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT03589846
Status
Enrolling By Invitation

Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Grass S88 Muscle Stimulator — DEVICE
    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).

Study Details

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.

Key Dates

Start date
Jul 26, 2018
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

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

Primary Outcome Measure

Basic physiologic measurements [ Time Frame: Collected during operative procedure, taking about 15 minutes. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvileTennessee37232-

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