Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

Single-Center Study of Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05870527

Enrollment

Registered

2023-05-23

Start date

2023-07-10

Completion date

2026-06-01

Last updated

2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

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

Interventions

DEVICEElectrical 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Pupillary Dilation during Procedure	Day 1 (During procedure - typically 1 hour in duration)	Pupillary dilation (mm) measured via non-invasive pupillary measurement camera.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJ. Thomas Roland Jr.

NYU Langone Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026