Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

Not Applicable

• Conditions: Hearing Loss

• 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

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