Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05870527
• Other study ID #: 23-00248
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 10, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Mydriasis

Intervention

Device:
• Electrical stimulator
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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupillary Dilation during Procedure	Pupillary dilation (mm) measured via non-invasive pupillary measurement camera.	Day 1 (During procedure - typically 1 hour in duration)