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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07000175
Enrollment
39
Registered
2025-06-02
Start date
2025-05-30
Completion date
2026-02-15
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sympathetic; Imbalance

Keywords

Heart Rates, Vagus Nerves

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.

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.

Interventions

DEVICETranscutaneous 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.

Sponsors

Bahçeşehir University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)

Masking description

Single blinding (investigator blinding)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate VariabilityBaseline and after 20 minutes of treatmentHeart rate variability will be measured with a 5-minute short measurement method over the chest, right arm and left arm.

Countries

Turkey (Türkiye)

Contacts

Primary ContactAlper Percin, Ph.D.
alperpercin@avrasya.edu.tr+905452557585

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026