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临床试验/NCT03255148
NCT03255148已完成1 期

Influence of Oxytocin on Resting State Neurophysiological Measures

KU Leuven1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2017年7月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
KU Leuven
入组人数
56
试验地点
1
主要终点
Change in heart rate variability after oxytocin administration

研究概览

简要总结

In this study, the investigators will explore the influence of oxytocin administration on several neurophysiological responses (EEG, skin conductance and heart rate) during rest.

详细描述

Oxytocin is known to influence several neurophysiological measures, such as heart rate, EEG and skin conductance during specific tasks (e.g., emotion recognition, fear learning and extinction). However, not much is known about the influence of oxytocin on those measures during rest. Therefore, in this randomized, placebo controlled, double blinded study, the investigators will investigate the influence of oxytocin during a resting period of 5 minutes. Heart rate, skin conductance, respiration and EEG will be measured before and after oxytocin or placebo administration. The investigators expect that oxytocin will increase the heart rate variability and decrease the skin conductance levels. Exploratory, the investigators will conduct a cross-frequency analysis of band power and asses the relationship between distinct indexes of sympathetic / parasympathetic balance.

Please note that this study is part of a larger study in which the investigators also asses the influence of oxytocin on neurophysiological responses elicited by direct gaze

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • right-handed
  • age between 18 and 35
  • Normal or adjusted-to-normal vision (with lenses only)
  • Dutch as mother tongue

排除标准

  • not right-handed
  • age below 18 or above 35
  • Need to wear glasses
  • Dutch not as mother tongue

研究组 & 干预措施

Oxytocin

Experimental

Syntocinon nasal spray (40 IU/ml; oxytocin, product code RVG 03716); single intranasal dose of 24 international units (IU; 3 puffs of 4 IU per nostril)

干预措施: Oxytocin (Drug)

Placebo

Placebo Comparator

saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)

干预措施: Placebo (Drug)

结局指标

主要结局

Change in heart rate variability after oxytocin administration

时间窗: Assessment over 5 minutes, before and after oxytocin or placebo administration

The influence of oxytocin administration on heart rate variability

次要结局

  • Change in skin conductance level after oxytocin administration(Assessment over 5 minutes, before and after oxytocin or placebo administration)

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kaat Alaerts

Prof. Dr. Kaat Alaerts

KU Leuven

研究点 (1)

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