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Completed

NCT Number: NCT03255148

Influence of Oxytocin on Resting State Neurophysiological Measures

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

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Key information

Conditions

Age range

18 year–38 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

KU Leuven

Leuven, 3000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Oxytocin

Drug

Syntocinon nasal spray

Other names: syntocinon

Placebo

Drug

Placebo nasal spray

Primary outcomes

  1. Change in heart rate variability after oxytocin administration

    Time frame: Assessment over 5 minutes, before and after oxytocin or placebo administration

    The influence of oxytocin administration on heart rate variability

Secondary outcomes

  1. Change in skin conductance level after oxytocin administration

    Time frame: Assessment over 5 minutes, before and after oxytocin or placebo administration

    The influence of oxytocin administration on skin conductance level

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Research Foundation Flanders

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2017
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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