Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05501236
Status
Recruiting
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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. During the DISE and second sleep study, fine-wire electrodes will be placed into the hypoglossal nerve or genioglossus muscle. Two more electrodes are placed transcutaneously, proximate to the bilateral branches of the cervicalis innervating the sternothyroid muscle in the anterior neck.

Study Details

Polysomnography (PSG) and drug-induced sleep endoscopy (DISE) are widely used diagnostic studies for assessing obstructive sleep apnea (OSA) severity and collapse patterns of the upper airway anatomy during sleep. Hypoglossal nerve stimulation (HNS) therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. The Investigators propose a study examining the physiologic effect of ansa cervicalis stimulation (ACS) alone and in combination with HNS during PSG and DISE.

Key Dates

First listed
Aug 15, 2022
Start date
Nov 3, 2022
Status verified
Jun 2026
Primary completion
May 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airway cross sectional diameter [ Time Frame: During DISE, approximately 15 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Katie Estes-Hartley, RPSGT
[email protected]
615-875-9214
Nicole L Jones, MS
[email protected]
615-936-2807
David T Kent, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Vanderbilt University Medical Center· Nashville, TN

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