Influence of Oxytocin on Resting State Neurophysiological Measures

July 31, 2019 updated by: Kaat Alaerts, KU Leuven
In this study, the investigators will explore the influence of oxytocin administration on several neurophysiological responses (EEG, skin conductance and heart rate) during rest.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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)
Drug: Oxytocin
Syntocinon nasal spray
Other Names:
  • syntocinon
PLACEBO_COMPARATOR: Placebo
saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)
Drug: Placebo
Placebo nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessment over 5 minutes, before and after oxytocin or placebo administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessment over 5 minutes, before and after oxytocin or placebo administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Research Foundation Flanders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 24, 2017

Primary Completion (ACTUAL)

May 18, 2018

Study Completion (ACTUAL)

May 18, 2018

Study Registration Dates

First Submitted

August 11, 2017

First Submitted That Met QC Criteria

August 18, 2017

First Posted (ACTUAL)

August 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SingleOT_REST_S56327

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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