跳至主要内容
临床试验/NCT07000175
NCT07000175招募中不适用

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

Bahçeşehir University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
39
试验地点
1
主要终点
Heart Rate Variability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Investigator)

盲法说明

Single blinding (investigator blinding)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (Device)

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.

干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (Device)

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.

干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (Device)

结局指标

主要结局

Heart Rate Variability

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alper Percin

Asst. Prof.

Bahçeşehir University

研究点 (1)

Loading locations...

相似试验

Comparison of Heart Rate Variability Measurement on... | 临床试验