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Influence of Oxytocin on Resting State Neurophysiological Measures

Sponsor
KU Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT03255148
Collaborator
Research Foundation Flanders (Other)
56
Enrollment
1
Location
2
Arms
9.8
Actual Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Influence of Oxytocin on Resting State Neurophysiological Measures
Actual Study Start Date :
Jul 24, 2017
Actual Primary Completion Date :
May 18, 2018
Actual Study Completion Date :
May 18, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in heart rate variability after oxytocin administration [Assessment over 5 minutes, before and after oxytocin or placebo administration]

      The influence of oxytocin administration on heart rate variability

    Secondary Outcome Measures

    1. Change in skin conductance level after oxytocin administration [Assessment over 5 minutes, before and after oxytocin or placebo administration]

      The influence of oxytocin administration on skin conductance level

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 38 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KU Leuven Leuven Belgium 3000

    Sponsors and Collaborators

    • KU Leuven
    • Research Foundation Flanders

    Investigators

    • Principal Investigator: Kaat Alaerts, PhD, KU Leuven

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaat Alaerts, Prof. Dr. Kaat Alaerts, KU Leuven
    ClinicalTrials.gov Identifier:
    NCT03255148
    Other Study ID Numbers:
    • SingleOT_REST_S56327
    First Posted:
    Aug 21, 2017
    Last Update Posted:
    Aug 1, 2019
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kaat Alaerts, Prof. Dr. Kaat Alaerts, KU Leuven
    resting state
    EEG
    skin conductance
    heart rate
    oxytocin
    Additional relevant MeSH terms:
    Oxytocin

    Study Results

    No Results Posted as of Aug 1, 2019