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Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

Primary Purpose

Hearing Loss

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrical stimulator
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vagal Nerve Stimulation during Cochlear Implantation Surgery

Vagal Nerve Stimulator Implantation

Arm Description

Participants undergoing cochlear implantation will receive electrical stimulation during the procedure to stimulate the Arnold's nerve to measure pupil dilation.

Control cohort undergoing vagal nerve stimulator implantation.

Outcomes

Primary Outcome Measures

Pupillary Dilation during Procedure
Pupillary dilation (mm) measured via non-invasive pupillary measurement camera.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2023
Last Updated
July 19, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05870527
Brief Title
Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
Official Title
Single-Center Study of Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
May 22, 2024 (Anticipated)
Study Completion Date
May 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The objective of this study is to determine if electrical stimulation of Arnold's Nerve, a branch of the vagus nerve, can result in vagal nerve response through the measurement of pupillary dilation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vagal Nerve Stimulation during Cochlear Implantation Surgery
Arm Type
Experimental
Arm Description
Participants undergoing cochlear implantation will receive electrical stimulation during the procedure to stimulate the Arnold's nerve to measure pupil dilation.
Arm Title
Vagal Nerve Stimulator Implantation
Arm Type
No Intervention
Arm Description
Control cohort undergoing vagal nerve stimulator implantation.
Intervention Type
Device
Intervention Name(s)
Electrical stimulator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pupillary Dilation during Procedure
Description
Pupillary dilation (mm) measured via non-invasive pupillary measurement camera.
Time Frame
Day 1 (During procedure - typically 1 hour in duration)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Thomas Roland Jr.
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.

Learn more about this trial

Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

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