Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

Not Applicable

• Conditions: Hearing Loss
• Interventions: Device: Electrical stimulator

• Registration Number: NCT05870527
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-23
• Study Start: 2023-07-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vagal Nerve Stimulation during Cochlear Implantation Surgery	Electrical stimulator	Participants undergoing cochlear implantation will receive electrical stimulation during the procedure to stimulate the Arnold's nerve to measure pupil dilation.

Primary Outcome Measures

Name	Time	Method
Pupillary Dilation during Procedure	Day 1 (During procedure - typically 1 hour in duration)	Pupillary dilation (mm) measured via non-invasive pupillary measurement camera.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States