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

NCT07000175 | Recruiting DMC

• 1 other identifier: AVU10002
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sympathetic; Imbalance

Keywords

Heart Rates; Vagus Nerves

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  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

Study Arms (3)

Measurement over the chest

ACTIVE COMPARATOR

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

Measurement over the right arm

ACTIVE COMPARATOR

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

Measurement over the left arm

ACTIVE COMPARATOR

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

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

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.

Measurement over the chest; Measurement over the left arm; Measurement over the right arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Avrasya University Physical Therapy Laboratory

Trabzon, Ortahisar, 61080, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Gillinov S, Etiwy M, Wang R, Blackburn G, Phelan D, Gillinov AM, Houghtaling P, Javadikasgari H, Desai MY. Variable Accuracy of Wearable Heart Rate Monitors during Aerobic Exercise. Med Sci Sports Exerc. 2017 Aug;49(8):1697-1703. doi: 10.1249/MSS.0000000000001284.

  PMID: 28709155 BACKGROUND

Study Officials

• Ramazan Cihad Yılmaz, Ph.D.

  Igdir University

  STUDY DIRECTOR

Central Study Contacts

Alper Percin, Ph.D.

CONTACT

+905452557585; alperpercin@avrasya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single blinding (investigator blinding)
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: A modelling will be created in which the same intervention will be applied to the three groups but the evaluations will be made differently.

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 2, 2025
• Study Start: May 30, 2025
• Primary Completion: January 30, 2026
• Study Completion: February 15, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)