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Enrolling by Invitation

NCT Number: NCT05870527

Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

Patients undergoing cochlear implantation:

  • is under the age of 18
  • has history of prior ear surgery, congenital ear malformation, or cochlear implantation
  • pregnant or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.
  • medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria 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 cochlear implantation
  • pregnant or breastfeeding
  • medical comorbidities resulting in exclusion are guided by the AANS exclusion criteria 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

Treatment and study plan

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.

Primary outcomes

  1. Pupillary Dilation during Procedure

    Time frame: Day 1 (During procedure - typically 1 hour in duration)

    Pupillary dilation (mm) measured via non-invasive pupillary measurement camera.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Single-Center Study of Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 23, 2023
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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