Comparison of Heart Rate Variability Measurement on the Arm and Chest in Vagus Nerve Stimulation

July 11, 2025 updated by: Alper Percin, Bahçeşehir University

Comparison of Heart Rate Variability Measurement on the Arm and Chest in Transcutaneous Auricular Vagus Nerve Stimulation

Healthy participants will be included in this study by invitation and randomised into three groups. Participants in each group will receive bilateral transcutaneous vagus nerve stimulation with the same frequency, current transit time and current intensity. Heart rate variability will be measured over the chest in the first group, over the right arm in the second group and over the left arm in the third group. Then, the differences between the groups in heart rate variability parameters (time-dependent, frequency-dependent) will be compared. The aim of this study is to examine the differences between heart rate variability measurements measured at different sites.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Heart rate variability is defined as the change in beat-to-beat interval, and the sympathetic and parasympathetic nervous system influences the change in beat-to-beat interval through cardiovascular connections. Heart rate variability measurement can be obtained by different methods. However, which method is more effective is controversial. The aim of this study was to investigate the differences between heart rate variability parameters measured on the chest, right arm and left arm.

Healthy participants aged 18-45 years will be included in the study. The inclusion criteria will be determined as being 18 years of age or older and not having any acute or chronic disease. Exclusion criteria will be determined as being previously involved in any neuromodulation intervention, smoking or alcohol use, and regular medication use.

Participants included in the study will be randomised into three groups and transcutaneous vagus nerve stimulation will be applied. The duration of treatment will be 20 minutes and single session stimulation will be performed. Current intensity, current passage time and frequency will be planned to be the same in each patient. Before and after stimulation, heart rate variability will be measured over the chest in the first group, over the right arm in the second group and over the left arm in the third group. Then, heart rate variability parameters (time-dependent, frequency-dependent) will be compared between the groups.

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Ortahisar
      • Trabzon, Ortahisar, Turkey, 61080
        • Recruiting
        • Avrasya University Physical Therapy Laboratory
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alper Percin, Asst. Prof.
        • Sub-Investigator:
          • Semiha Yenisehir, Asst. Prof.
        • Sub-Investigator:
          • Ramazan Cihad Yılmaz, Asst. Prof.
        • Sub-Investigator:
          • Ali Veysel Ozden, Asst. Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years of age or older
  • To know how to read and write Turkish
  • Not having any acute or chronic disease

Exclusion Criteria:

  • Previous application of any neuromodulation method
  • Smoking or alcohol use
  • Use of any supplementary medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Measurement over the chest
Heart rate variability will be measured on the chest for 5 minutes before and after transcutaneous vagus nerve stimulation.
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Non-invasive transcutaneous vagus nerve stimulation with special earphones placed in the ear will be applied to the participants for 20 minutes and a single session.
Active Comparator: Measurement over the right arm
Heart rate variability will be measured on the right arm for 5 minutes before and after transcutaneous vagus nerve stimulation.
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Non-invasive transcutaneous vagus nerve stimulation with special earphones placed in the ear will be applied to the participants for 20 minutes and a single session.
Active Comparator: Measurement over the left arm
Heart rate variability will be measured on the left arm for 5 minutes before and after transcutaneous vagus nerve stimulation.
Device: Transcutaneous Auricular Vagus Nerve Stimulation
Non-invasive transcutaneous vagus nerve stimulation with special earphones placed in the ear will be applied to the participants for 20 minutes and a single session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: Baseline and after 20 minutes of treatment
Heart rate variability will be measured with a 5-minute short measurement method over the chest, right arm and left arm.
Baseline and after 20 minutes of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahçeşehir University

Investigators

  • Study Director: Ramazan Cihad Yılmaz, Ph.D., Igdir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2025

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

February 15, 2026

Study Registration Dates

First Submitted

May 23, 2025

First Submitted That Met QC Criteria

May 23, 2025

First Posted (Actual)

June 2, 2025

Study Record Updates

Last Update Posted (Actual)

July 14, 2025

Last Update Submitted That Met QC Criteria

July 11, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AVU10002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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