Effects of Transcutaneous Vagal Nerve Stimulation (tVNS) on Blood Pressure, Heart Rate and Autonomic Control in Hypertensive Subjects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 28
- 主要终点
- Autonomic control response to transcutaneous vagal nerve stimulation
研究概览
简要总结
The vagal stimulation is a promising therapy for a lot of disorders as well as hemodynamic regulatory way. In order to minimize the harm of a surgery chip implantation, actually it was developing a non-invasive device that is able to stimulate the auricular branch of vagal nerve. It has been shown that trans-auricular vagal stimulation (tVNS) causes direct stimulation of the vagal nerve. However, there are still no strong evidences about it actions regarding the autonomic modulation. The aim of this study is to evaluate effects of tVNS on heart rate, blood pressure and the autonomic control in healthy and hypertensive subjects, at rest and after orthostatic position
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normotensive group Inclusion Criteria:
- •healthy volunteers
- •sign the consent term
- •Normotensive group
排除标准
- •alcoholism
- •drug treatment
- •skin lesion in the ear region
- •chronic or acute diseases
- •pregnancy
- •be participating in another research protocol
- •high performance athletes
- •recent surgery
- •vaso-vagal syndrome
- •Hypertensive group Inclusion Criteria:
- •hypertensive diagnosis (with or without anti-hypertensive drugs treatment) or
- •ambulatory blood pressure monitoring (ABPM) >130/85
- •sign the consent term
- •Hypertensive group Exclusion Criteria:
- •alcoholism
- •beta-blockers treatment
- •skin lesion in the ear region
- •associated diseases
- •pregnancy
- •be participating in another research protocol
- •high performance athletes
- •recent surgery
- •vaso-vagal syndrome
结局指标
主要结局
Autonomic control response to transcutaneous vagal nerve stimulation
时间窗: 40 minutes
sympathetic and parasympathetic response to non-invasive vagal nerve stimulation
次要结局
- Heart Rate changes to transcutaneous vagal nerve stimulation(40 minutes)
- Blood pressure changes to transcutaneous vagal nerve stimulation(40 minutes)