Sponsor study identifier
Secondary identifiers
interventional
82
1 country
1
Study Start
August 19, 2019
Actual (reported)Primary Completion
November 15, 2022
Actual (reported)Study Completion
November 15, 2022
Actual (reported)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. \[This study was originally described in NCT04206540, however a separate record has been created to more accurately reflect the independence of the individual studies supported by the ABVN 1 grant.\]
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 19, 2019
Actual (reported)November 15, 2022
Actual (reported)November 15, 2022
Actual (reported)October 12, 2026
Actual (reported)October 19, 2026
Actual (reported)Number of Participants with Vagal Nerve Activation
The number of healthy volunteers in which vagal nerve compound action potentials (CNAPs) can be detected during transcutaneous stimulation of the auricular branch of the vagal nerve.
Day 1
Number of participants with an increase in surface electrogastrogram amplitude
The amplitude of the surface electrogastrogram (EGG) in healthy volunteers will be measured at baseline and during vagal maneuvers to determine whether vagal maneuvers increase surface EGG amplitude.
Day 1
Percent Change in Heart Rate Variability
This will be measured in SDNN (standard deviation of normal to normal intervals in the EKG). The participants' average SDNN during vagal maneuvers is compared with the average baseline SDNN as a percent change of SDNN.
Day 1
Healthy volunteers aged 18-80 years old who will perform 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.
Indiana University Hosptial
Indianapolis, Indiana, 46202, United States
Thomas V Nowak, MD
Indiana University
82 participants (actual enrollment reported by the registry).
First Submitted
October 12, 2026
First Posted
October 19, 2026
Study Start
August 19, 2019
Actual (reported)Spire Health Remote Patient Monitor Human Factors Summative Study Protocol
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.
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Primary Completion
November 15, 2022
Actual (reported)Study Completion
November 15, 2022
Actual (reported)Last Updated
October 19, 2026
Record last verified: 2026-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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