Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

Last updated: March 24, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Enrolling

Phase

N/A

Condition

Hearing Loss

Hearing Impairment

Deafness

Treatment

Electrical stimulator

Clinical Study ID

NCT05870527
23-00248
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients undergoing cochlear implantation:

  • will be undergoing surgery for a cochlear implant

  • is over the age of 18

  • is willing to participate in the study

Patients undergoing vagal nerve stimulator implantation:

  • will be undergoing implantable vagal nerve stimulation

  • is over the age of 18

  • is willing to participate in the study

Exclusion

Exclusion Criteria:

Patients undergoing cochlear implantation:

  • is under the age of 18

  • has history of prior ear surgery, congenital ear malformation, or cochlearimplantation

  • pregnant or breastfeeding patients cannot undergo the standard-of-care implantationprocedures required for participation in the study.

  • medical comorbidities resulting in exclusion are guided by the AANS exclusioncriteria for VNS and include the following:

  • One vagus nerve

  • Receiving other concurrent forms of brain stimulation

  • Heart arrhythmias or other heart abnormalities

  • Dysautonomias (abnormal functioning of the autonomic nervous system)

  • Lung diseases or disorders (shortness of breath, asthma, etc.)

  • Ulcers (gastric, duodenal, etc.)

  • Vasovagal syncope (fainting)

  • Pre-existing hoarseness

Patients undergoing vagal nerve stimulator implantation:

  • is under the age of 18

  • has history of prior ear surgery, congenital ear malformation, or cochlearimplantation

  • pregnant or breastfeeding

  • medical comorbidities resulting in exclusion are guided by the AANS exclusioncriteria for VNS and include the following:

  • One vagus nerve

  • Receiving other concurrent forms of brain stimulation

  • Heart arrhythmias or other heart abnormalities

  • Dysautonomias (abnormal functioning of the autonomic nervous system)

  • Lung diseases or disorders (shortness of breath, asthma, etc.)

  • Ulcers (gastric, duodenal, etc.)

  • Vasovagal syncope (fainting)

  • Pre-existing hoarseness

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Electrical stimulator
Phase:
Study Start date:
July 10, 2023
Estimated Completion Date:
June 30, 2026

Study Description

The objective of this study is to determine if electrical stimulation of Arnold's Nerve, a branch of the vagus nerve, can result in vagal nerve response through the measurement of pupillary dilation

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

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