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临床试验/NCT06086236
NCT06086236已完成不适用

Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Basic Autonomic Nervous System Activity

Bahçeşehir University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年4月1日最近更新:
适应症

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
2
主要终点
Systolic Blood Pressure

研究概览

简要总结

Transcutaneous Auricular Vagus nerve stimulation may be successful in cardiac modulation because of the cardiac connections of the vagal nerve. Therefore, in order to observe the cardiac effects, it was analysed the changes in pulse rate, systolic and diastolic blood pressure after transcutaneous auricular vagus nerve stimulation application.

详细描述

Participants were divided into four groups (Figure 1) according to PNS and SNS indexes as Group 1 (PNS index <-2, SNS index >+2), Group 2 (PNS index <-2, SNS index <+2), Group 3 (PNS index >-2, SNS index >+2), Group 4 (PNS index >-2, SNS index <+2). Participants were assessed with blood pressure, pulse rate and HRV before and after taVNS stimulation. Sympathetic nervous system (SNS) index and parasympathetic nervous system (PNS) index values were assumed to be between -2 and +2 (95%) in the normal population according to Kubios software, and the grouping method was based on this situation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The evaluations were carried out by the second researcher

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 40 years old.
  • No previous vagus nerve stimulation

排除标准

  • Using of any drug, alcohol or smoking.
  • Pregnancy.
  • Known history of acute or chronic illness.
  • Being in the post or peri-menopausal stage.

结局指标

主要结局

Systolic Blood Pressure

时间窗: Up to 6 Months

The systolic blood pressure of the participants was measured with an electronic blood pressure monitor.

Diastolic Blood Pressure

时间窗: Up to 6 Months

The diastolic blood pressure of the participants was measured with an electronic blood pressure monitor.

Pulse Rate

时间窗: Up to 6 Months

The pulse rate of the participants was measured with an electronic blood pressure monitor.

次要结局

未报告次要终点

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alper Percin

Principal Investigator

Bahçeşehir University

研究点 (2)

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