Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
United States30 participantsStarted 2023-07-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pupillary Dilation during Procedure
Timeframe: Day 1 (During procedure - typically 1 hour in duration)