Clinical trial NCT05870527: Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
Official title: Single-Center Study of Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hearing Loss
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Pupillary Dilation during Procedure
timeFrame: Day 1 (During procedure - typically 1 hour in duration)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: J. Thomas Roland Jr.
role: PRINCIPAL_INVESTIGATOR
References: