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 range18 Years
SexALL
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:
…
What they're measuring
1
Pupillary Dilation during Procedure
Timeframe: Day 1 (During procedure - typically 1 hour in duration)