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NCT Number: NCT07000175

Comparison of Heart Rate Variability Measurement on the Arm and Chest in 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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Avrasya University Physical Therapy Laboratory

Trabzon, Ortahisar, 61080, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ali Veysel Ozden, Asst. Prof.

SUB_INVESTIGATOR

Alper Percin, Asst. Prof.

PRINCIPAL_INVESTIGATOR

Ezgi Albayrak

CONTACT

[email protected]

Ramazan Cihad Yılmaz, Asst. Prof.

SUB_INVESTIGATOR

Semiha Yenisehir, Asst. Prof.

SUB_INVESTIGATOR

Yavuz Ozoran, Prof.Dr.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alper Percin, Ph.D.

CONTACT

[email protected]

+905452557585

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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