Multi-device Testing for Autonomic Nervous System Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Changes of HRV recording parameters
研究概览
简要总结
The Vagus nerve (VN) serve as an "unconscious inner brain" that integrates messages from the body and provides metabolic homeostatic regulation to various organs.In this study the investigators want to compare different ways to stimulate the vagus nerve to assess their respective effects compared to a sham stimulation.
Each participant will be exposed in a random way to 7 different ways to stimulate the VN:
- Manual Head Massage
- Mechanical Head Massager (BREO Inc. Helmet)
- Low laser Therapy (LLT)
- Sham LLT
- Transcutaneous Electrical Nervous Stimulation (TENS) ear stimulation (as testing phase prototype device)
- Deep and slow breathing (as testing intervention based on video app)
- Relaxed reading time (as control situation)
Therefore, within the same design the investigators want to conduct two separate studies that should lead to two separate publications:
- Study 1: comparison of manual head massage to mechanical Helmet massager and relaxed reading
- Study 2: comparison of LLT with sham LLT and relaxed reading
The two other interventions: TENS ear stimulation and Deep and Slow breathing are purely observational to gain knowledge in context of a convenient design.
详细描述
OBJECTIVES Overall objective is to assess the respective effects of the different ways to stimulate the Vagus Nerve on the Heart Rate Variability (HRV) parameters: High Frequency (HF), Low Frequency (LF), Total Power (TP), Heart rate (HR), and blood pressure (BP).
Specific objectives:
- Comparison of Manual Head Massage to Mechanical Head Massager to Control situation
- Comparison of Low Laser Therapy (LLT) to sham LLT to control situation
- Effects of TENS ear stimulation (descriptive)
- Effects of Deep and Slow breathing (descriptive)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants may be aware partially or totally of the nature of the intervention. For instance Manual Head Massage or Helmet Massager cannot be blind. However, for LLT or sham LLT the participants will remain blind. Indeed, Relaxed reading time is known by the participants
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 20 to 40 in normal context
排除标准
- •To have work night shift the night before
- •To use certain drugs that affect the ANS (beta blockers, beta stimulant, hypnotic, for instance)
- •To be in situation of unusual life stress
- •To have a chronic disease that require some daily treatment
- •Not to stay in Beijing for the duration of the investigation
结局指标
主要结局
Changes of HRV recording parameters
时间窗: Changes from baseline HRV parameters at post intervention 15 minutes
The investigators will use the BIOPAC Machine that captures ECG data, signals were sampled at 500 Hz throughout the testing. Recorded data were reviewed and analyzed using AcqKnowledge software version 4.2. The HRV recording parameters include: (1) Very Low Frequency (VLF) (\< 0.04 Hz), (2) Low Frequency (LF) (0.04 - 0.15 Hz), (3) High Frequency (HF) (0.15 to 0.4 Hz), (4) Total Power (TP), which was calculated by summing up all frequency bands, (5) Total Power partial (TPp) (HF + LF), (6) HFnu (normalized unit of HF), (7) Ratio (HF divided by LF).
次要结局
- Change of Heart Rate(Change from baseline heart rate at post intervention 15 minutes)
- Change of Blood Pressure (Systolic and Diastolic Blood pressure)(Change from baseline systolic and diastolic blood pressure at post intervention 15 minutes)
- Change of Body Tension(Change from baseline body tension at post intervention 15 minutes)
研究者
yilong Wang
Professor
Beijing Tiantan Hospital