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COMPLETED
NCT07881276
NA

ABVN Phase 1 - Vagal Maneuvers

Sponsor: Indiana University

View on ClinicalTrials.gov

Summary

The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators hope to be able to measure the activity of the vagus nerve when it is stimulated through simple physical techniques. The overall purpose of the ABVN 1 grant is to evaluate the effects of noninvasive stimulation on vagal nerve function. This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate the effect of vagal stimulation through simple physical techniques (vagal maneuvers) in healthy subjects. \[This study was originally described in NCT04206540, however a separate record has been created to more accurately reflect the independence of the individual studies supported by the ABVN 1 grant.\]

Official title: Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Compound Nerve Action Potentials (CNAPs) Phase 1 - Vagal Maneuvers in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2019-08-19

Completion Date

2022-11-15

Last Updated

2026-10-19

Healthy Volunteers

Yes

Interventions

OTHER

Vagal Maneuvers

Subjects will be asked to perform various maneuvers to stimulate the vagus nerve: * Cough: 6 to 8 forceful coughs over 5 to 10 seconds. * Cold stimulus to face: Have an ice cold wash cloth placed on their face for 10 seconds. * Carotid massage: While the neck is extended and the head is turned away from the side being massaged, pressure is applied underneath the angle of the jaw in a gentle circular motion for about 10 seconds. * Gagging: a tongue depressor is briefly inserted into the back of the mouth touching the back of the throat. * Valsalva maneuver: Subjects will be asked to bear down as if having a bowel movement. They will be asked to blow through a mouthpiece that is hooked to a device that measures how hard they are blowing. Alternatively, they can blow through the barrel of a 10 ml syringe for 15-20 seconds. * Eating: Subjects will be asked to drink 8 ounces of water and/or Ensure Original after fasting overnight.

DEVICE

Multi-Electrode Array (MEA) Recording

In some participants, cervical neck electrodes used during the eating tasks may include the multi electrode array (MEA). As an alternative to standard single ECG electrodes, the MEA can be placed on either side of the neck over the area of the vagus nerve to record a wider signal of electrical activity.

Locations (1)

Indiana University Hosptial

Indianapolis, Indiana, United States