Non-Invasive Peripheral Neuromodulation to Augment HRV in Healthy Adults
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of patients with 15% or HRV change immediately after neurostimulation session
研究概览
简要总结
Brief Summary: A randomized double-blinded, sham-controlled, crossover study
Condition or Disease: impaired autonomic balance measured by heart rate variability
详细描述
A randomized double-blinded, sham-controlled, crossover study
Condition or Disease: impaired autonomic balance measured by heart rate variability
Intervention/treatment:
Device: ReguRate RR2 neurostimulation system Device: Sham ReguRate RR2 neurostimulation system
Study Design:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria :
- •Healthy male and female volunteers ages 25-60
- •2 minute HRV measurement with SDNN<35 ms (below 35 ms)
- •Participants able and willing to comply with the study protocol
- •Participants able and willing to sign a written informed consent
排除标准
- •Exclusion criteria :
- •Participant with a known cardiovascular disease
- •Participants with COPD
- •Participants with any known history of epilepsy
- •Participants with detected arrhythmia on test day
- •Participants with implanted electrical and/or neurostimulation device (such as cardiac pace maker/defibrillator/VNS stimulator/SNS stimulator/occipital nerve stimulator/deep brain stimulator etc.)
- •Heavy smokers (more than 1 package of cigarets a day)
- •Participants with a plan to change medications
- •History of vasovagal syncope
- •Pregnancy or bleeding
- •Participants enrolled in another clinical trial
研究组 & 干预措施
Active Comparator: ReguRate RR2 active
Device: ReguRate neurostimulation device
干预措施: ReguRate neurostimulation (Device)
Sham Comparator: ReguRate RR2 sham.
Device: Sham ReguRate neurostimulation - mock sham stimulation mode
干预措施: ReguRate neurostimulation (Device)
结局指标
主要结局
Percentage of patients with 15% or HRV change immediately after neurostimulation session
时间窗: 1 week
HRV augmentation
次要结局
- Decrease in heart rate(1 week)
研究者
Prof. Ahud Sternberg
Chairman of Helsinki Ethics Committee
Hillel Yaffe Medical Center