Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
NCT ID: NCT05870527
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2023-07-10
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
Electrical stimulator
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.
Vagal Nerve Stimulator Implantation
Control cohort undergoing vagal nerve stimulator implantation.
No interventions assigned to this group
Interventions
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Electrical stimulator
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* 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
* 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
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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J. Thomas Roland Jr.
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Other Identifiers
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23-00248
Identifier Type: -
Identifier Source: org_study_id
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