Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
Single-Center Study of Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2023
CompletedFirst Posted
Study publicly available on registry
May 23, 2023
CompletedStudy Start
First participant enrolled
July 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
January 28, 2026
January 1, 2026
2.9 years
May 12, 2023
January 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Pupillary Dilation during Procedure
Pupillary dilation (mm) measured via non-invasive pupillary measurement camera.
Day 1 (During procedure - typically 1 hour in duration)
Study Arms (2)
Vagal Nerve Stimulation during Cochlear Implantation Surgery
EXPERIMENTALParticipants undergoing cochlear implantation will receive electrical stimulation during the procedure to stimulate the Arnold's nerve to measure pupil dilation.
Vagal Nerve Stimulator Implantation
NO INTERVENTIONControl cohort undergoing vagal nerve stimulator implantation.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Thomas Roland Jr.
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2023
First Posted
May 23, 2023
Study Start
July 10, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
January 28, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to justin.cottrell@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: justin.cottrell@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.