Effects of Non Invasive Vagus Nerve Stimulation on Heart Rate Variability in Healthy Subjects and on Muscle Sympathetic Nerve Activity
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Heart rate variability modulation
研究概览
简要总结
To demonstrate the effect of non invasive vagus nerve (VNS) stimulation on heart rate variability and MSNA signal.
详细描述
First part: Assessment of the muscle sympathetic nerve activity (MSNA) at baseline using microneurography performed on the superficial peroneal nerve.
Second part: Acquisition of the MSNA signal during non-invasive VNS and apnea. Non-invasive VNS is performed using several frequencies of stimulation. Maximal and voluntaries apnea are performed at the end of the expiration.
Continuous recording of the following parameters:
- non-invasive arterial blood pressure
- R-R interval
- electrocardiogram
- MSNA activity
- respiratory curve signal
- respiratory rate, oxygen saturation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Investigators are double-blinded for both experimental procedures and data analyzes.
Volunteers are blinded to the site of stimulation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •>18 years old
排除标准
- •pregnancy and breastfeeding
- •alcool/energy drinks/coffee consumption, exertion 24h before the participation
结局指标
主要结局
Heart rate variability modulation
时间窗: 4 hours
Modulation of heart rate variability assessed through analysis of MSNA signal
次要结局
- Non-invasive vagus nerve stimulation(4hours)
- Profile of response for MSNA(4 hours)