Comparison of the Effect of Transcutaneous Auricular Vagus and Trigeminal Nerve Stimulation on Heart Rate Variability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Heart Rate Variability
研究概览
简要总结
The aim of this study was to compare the results between transcutaneous auricular vagus nerve stimulation and trigeminal nerve stimulation with the results obtained from heart rate variability, pulse and blood pressure measurements and to reveal which method is more effective in autonomic nervous system neuromodulation.
Hypotheses of the study:
H0: Vagus nerve stimulation is more effective than trigeminal nerve simulation in terms of heart rate variability.
H1: Trigeminal nerve stimulation is more effective than vagus nerve simulation in terms of heart rate variability.
详细描述
In this study, 80 healthy participants (40 males, 40 females) aged between 20-50 years were randomized (www.randomizer.org) into four groups by computer software. After randomisation, one group was received transcutaneous vagus nerve stimulation inside the ear, while the other group was received trigeminal nerve stimulation above the ear.The third group received sham transcutaneous vagus nerve stimulation and the fourth group received sham trigeminal nerve simulation. Heart rate variability, pulse rate and blood pressure measurements were performed to determine which stimulation method is more effective. Heart rate variability was analysed with Kubios HRV programme after the 5-minute short measurement method. SNS, PNS and Stress Index and LF, HF and LF/HF parameters were evaluated in heart rate variability sub-parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be 18 years of age or older,
- •Not having any acute or chronic disease.
排除标准
- •Having any acute or chronic disease,
- •Having previously undergone vagus nerve stimulation or trigeminal nerve stimulation.
结局指标
主要结局
Heart Rate Variability
时间窗: Pre-intervention and immediately after the intervention
5 minutes of heart rate variability was measured.
次要结局
- Systolic and Diastolic Blood Pressure(Pre-intervention and immediately after the intervention)
研究者
Alper Percin
Asst. Prof.
Bahçeşehir University