~3 spots leftby Jun 2025

Vagal Nerve Stimulation for Dilated Pupil

Recruiting in Palo Alto (17 mi)
Overseen byJ. Thomas Roland Jr.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: NYU Langone Health
No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing if stimulating a nerve in the ear with electricity during ear surgery can make the pupils get bigger.

Eligibility Criteria

This trial is for adults over 18 years old who are undergoing cochlear implantation or vagal nerve stimulator implantation and are willing to participate. It's not for those with a history of ear surgery, congenital malformations, pregnant/breastfeeding individuals, or anyone with certain medical conditions like heart arrhythmias, lung diseases, ulcers, dysautonomias, vasovagal syncope, or pre-existing hoarseness.

Inclusion Criteria

I am over 18 and getting a vagal nerve stimulator implant.
I am over 18 and getting a cochlear implant.
I am scheduled for cochlear implant surgery.
+3 more

Exclusion Criteria

You will be excluded if you have a history of fainting due to a medical condition.
Patients undergoing vagal nerve stimulator implantation: pregnant or breastfeeding
I do not have lung diseases like asthma causing shortness of breath.
+11 more

Participant Groups

The study tests how the pupil dilates when Arnold's Nerve (part of the vagus nerve) is stimulated with an electrical device during routine cochlear implant surgery. The aim is to understand the connection between this stimulation and changes in pupil size.
2Treatment groups
Experimental Treatment
Active Control
Group I: Vagal Nerve Stimulation during Cochlear Implantation SurgeryExperimental Treatment1 Intervention
Participants undergoing cochlear implantation will receive electrical stimulation during the procedure to stimulate the Arnold's nerve to measure pupil dilation.
Group II: Vagal Nerve Stimulator ImplantationActive Control1 Intervention
Control cohort undergoing vagal nerve stimulator implantation.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?

NYU Langone HealthLead Sponsor

References