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临床试验/NCT03854539
NCT03854539已完成不适用

Salivary Alpha Amylase as a Biomarker of Transdermal Vagus Nerve Stimulation

Arkansas Tech University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年3月31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
100
试验地点
2
主要终点
Change in Salivary Alpha Amylase concentration.

研究概览

简要总结

The proposed project tests the hypothesis that salivary alpha amylase concentration is a reliable biomarker of the effect of transdermal vagus nerve stimulation (tVNS) in humans.

详细描述

The study examines the capacity of tVNS to alter the concentrations of salivary alpha amylase. Changes in salivary alpha amylase concentrations reflect alteration of CNS structures anatomically linked to the vagus, thus alertation of alpha amylase would indicate the efficacy of tVNS. This study is intended to study basic mechanisms and is not directed toward the treatment of any disease state. Particapants taking part in the study will spend about one hour in a single session.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Healthy individuals

排除标准

  • 未提供

结局指标

主要结局

Change in Salivary Alpha Amylase concentration.

时间窗: Within single one hour session change in concentration immediately prior to and following stimulation and 5 minutes post-stimulation

Biomarker of autonomic arousal level

次要结局

  • Change in Heart Rate Variability.(Within single one hour session change in heart rate variability immediately prior to and following stimulation period.)

研究者

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

Rodney Roosevelt

Assistant Professor

Arkansas Tech University

研究点 (2)

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