Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Basic Autonomic Nervous System Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Heart Rate Variability Parameters-LF (Low Frequency)
研究概览
简要总结
There are no generally accepted values for transcutaneous vagus nerve stimulation (taVSS application parameters (amplitude, frequency, intensity, duration, side) yet, therefore there are heterogeneous applications in studies. Although positive effects have been shown in different neurological, psychiatric and musculoskeletal diseases, taVSS treatment is not available yet. It is not clear which parameters are important in patient selection.In this study, it was aimed to investigate the change of taVSS effect in healthy individuals according to the level of autonomic nervous system activity before stimulation.
详细描述
Healthy individuals between the ages of 18-45 without any disease will be included in the study. Male and female participants will be included in the study. Heart rate variability will be measured after participants are included in the study. A short 5-minute measurement will be made with the Polar H7 device, which can be measured with the belt attached to the chest. Heart Rate Variability measurement will be analyzed with the Kubios HRV program. Participants will be distributed to groups according to the SNS index and PNS index values obtained as a result of the Kubios analysis. According to the index scores obtained, the distribution of the groups will be made as <-2, between -2 and +2 and >2. Afterwards, 20 minutes of taVSS stimulation will be performed. As a vagus stimulation protocol, bilateral auricular stimulation and stimulation frequency of 10 Hz (Heartz), pulse width of 300 µs (microseconds) for 20 minutes, biphasic application will be given to each participant 2 times, with at least 48 hours between them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Healthy participants between the ages of 18-45 will be included in the study.
排除标准
- •Having an acute or chronic disease,
- •Having previously undergone transcutaneous vagus nerve stimulation,
- •Not smoking or using alcohol,
- •Being in the post-menopausal stage in women,
- •Being in the post-andropausal period in men,
- •Being on constant medication,
- •In menstruating women, stimulation and heart rate assessment will be postponed to the next week.
研究组 & 干预措施
Health Participants
Participants in this group will be measured heart rate variability before and after transcutaneous vagus nerve stimulation.
干预措施: Transcutaneous Vagus Nerve Stimulation (Device)
结局指标
主要结局
Heart Rate Variability Parameters-LF (Low Frequency)
时间窗: 5 minutes (short measurement) measurement of heart rate variability
Power in the Low Frequency band of the HRV spectrum, often between 0.04 - 0.15 Hz, often reported in units of milliseconds-squared.
Heart Rate Variability Parameters-Stress Index
时间窗: 5 minutes (short measurement) measurement of heart rate variability
Stress index which is a geometric measure of HRV reflecting cardiovascular system stress. High values of SI indicate reduced variability and high sympathetic cardiac activation.
Heart Rate Variability Parameters-RMSSD
时间窗: 5 minutes (short measurement) measurement of heart rate variability
RMSSD is a measure of short-term (beat-by-beat) variability. It equals the root mean square of successive differences.
Heart Rate Variability Parameters-HF (High Frequency)
时间窗: 5 minutes (short measurement) measurement of heart rate variability
Power in the High Frequency band of the HRV spectrum, often between 0.15-0.40 Hz, often reported in units of milliseconds-squared.
Heart Rate Variability Parameters-PNS Index
时间窗: 5 minutes (short measurement) measurement of heart rate variability
Parasympathetic cardiac activity is known to 1) decrease heart rate (i.e. increase the time interval between successive heart beats), 2) increase HRV via enhanced respiratory sinus arrhythmia (RSA) component (i.e. increasing the quick changes in RR interval linked to respiration - shortening of RR intervals during inhalation and lengthening of RR intervals during exhalation), and 3) decrease the ratio between lower frequency and higher frequency oscillations in HRV time series (i.e. increase the relative amount of quick RSA originated fluctuations in HRV compared to slower short-term fluctuations)
Heart Rate Variability Parameters-LF/HF Ratio
时间窗: 5 minutes (short measurement) measurement of heart rate variability
LF/HF Ratio: A ratio of Low Frequency to High Frequency.
Heart Rate Variability Parameters-SNS Index
时间窗: 5 minutes (short measurement) measurement of heart rate variability
Sympathetic cardiac activity is known to 1) increase heart rate, 2) decrease HRV, reducing especially quick RSA related changes in RR interval, and 3) increase the ratio between lower frequency and higher frequency oscillations in HRV data
次要结局
未报告次要终点
研究者
Alper Percin
Principal Investigator
Bahçeşehir University