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

NCT ID: NCT07000175

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2026-02-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sympathetic; Imbalance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A modelling will be created in which the same intervention will be applied to the three groups but the evaluations will be made differently.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators
Single blinding (investigator blinding)

Study Groups

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Measurement over the chest

Heart rate variability will be measured on the chest for 5 minutes before and after transcutaneous vagus nerve stimulation.

Group Type ACTIVE_COMPARATOR

Transcutaneous Auricular Vagus Nerve Stimulation

Intervention Type 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 right arm

Heart rate variability will be measured on the right arm for 5 minutes before and after transcutaneous vagus nerve stimulation.

Group Type ACTIVE_COMPARATOR

Transcutaneous Auricular Vagus Nerve Stimulation

Intervention Type 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 left arm

Heart rate variability will be measured on the left arm for 5 minutes before and after transcutaneous vagus nerve stimulation.

Group Type ACTIVE_COMPARATOR

Transcutaneous Auricular Vagus Nerve Stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bahçeşehir University

OTHER

Sponsor Role lead

Responsible Party

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Alper Percin

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramazan Cihad Yılmaz, Ph.D.

Role: STUDY_DIRECTOR

Igdir University

Locations

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Avrasya University Physical Therapy Laboratory

Trabzon, Ortahisar, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Alper Percin, Ph.D.

Role: CONTACT

+905452557585

Facility Contacts

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Yavuz Ozoran, Prof.Dr.

Role: primary

Ezgi Albayrak

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 28709155 (View on PubMed)

Other Identifiers

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AVU10002

Identifier Type: -

Identifier Source: org_study_id

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