Skip to main content
Clinical Trials/NCT03255148
NCT03255148
Completed
Phase 1

Influence of Oxytocin on Resting State Neurophysiological Measures

KU Leuven1 site in 1 country56 target enrollmentJuly 24, 2017
ConditionsOxytocin
InterventionsOxytocinPlacebo

Overview

Phase
Phase 1
Intervention
Oxytocin
Conditions
Oxytocin
Sponsor
KU Leuven
Enrollment
56
Locations
1
Primary Endpoint
Change in heart rate variability after oxytocin administration
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
July 24, 2017
End Date
May 18, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
KU Leuven
Responsible Party
Principal Investigator
Principal Investigator

Kaat Alaerts

Prof. Dr. Kaat Alaerts

KU Leuven

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Oxytocin

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)

Intervention: Oxytocin

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

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

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

Study Sites (1)

Loading locations...

Similar Trials