Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05870527
Status
Enrolling By Invitation

Conditions

  • Hearing Loss

Eligibility Criteria

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

Interventions

  • Electrical stimulator — DEVICE
    Electrical stimulation will be used to stimulate the Arnold's nerve and measure pupil dilation. The electrical stimulator is part of the standard facial nerve monitoring unit that we utilize in cochlear implantation and will be setup prior to surgery in standard fashion. The device allows for constant current stimulation, with stimulus range between 0-30 mA.

Study Details

The research team will evaluate pupillary dilation from vagal nerve stimulation of Arnold's Nerve, a branch of the vagus nerve, during routine cochlear implantation surgery.

Key Dates

Start date
Jul 10, 2023
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Vagal Nerve Stimulation during Cochlear Implantation Surgery
    Participants undergoing cochlear implantation will receive electrical stimulation during the procedure to stimulate the Arnold's nerve to measure pupil dilation.
  • No Intervention: Vagal Nerve Stimulator Implantation
    Control cohort undergoing vagal nerve stimulator implantation.

Primary Outcome Measure

Pupillary Dilation during Procedure [ Time Frame: Day 1 (During procedure - typically 1 hour in duration) ]

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By research site
NYU Langone Health· New York, NY

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