What this study is
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.
What's being tested
- Electrical stimulator
Intervention · DEVICE
Electrical stimulation will be used to stimulate the Arnold's nerve and measure pupil dilation. The electrical stimulator is part of the standard facial nerve monitoring unit that we utilize in cochlear implantation and will be setup prior to surgery in standard fashion. The device allows for constant current stimulation, with stimulus range between 0-30 mA.
Study details
- Official title
- Single-Center Study of Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
- Sponsor
- NYU Langone Health
- Conditions
- Hearing Loss
- Enrolling
- 30 people
- Starts
- 2023-07-10
- Est. completion
- 2026-06
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNYU Langone Health
New York, New York, United States
Study team
Sponsor
NYU Langone Health
Study ID 23-00248
Principal investigator
J. Thomas Roland Jr.
NYU Langone Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.