Single-Center Study of Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
Overview
- Phase
- Not Applicable
- Intervention
- Electrical stimulator
- Conditions
- Hearing Loss
- Sponsor
- NYU Langone Health
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pupillary Dilation during Procedure
- Status
- Enrolling By Invitation
- Last Updated
- 3 months ago
Overview
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
Investigators
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.)
Arms & Interventions
Vagal Nerve Stimulation during Cochlear Implantation Surgery
Participants undergoing cochlear implantation will receive electrical stimulation during the procedure to stimulate the Arnold's nerve to measure pupil dilation.
Intervention: Electrical stimulator
Vagal Nerve Stimulator Implantation
Control cohort undergoing vagal nerve stimulator implantation.
Outcomes
Primary Outcomes
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.