<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03255148</url>
  </required_header>
  <id_info>
    <org_study_id>SingleOT_REST_S56327</org_study_id>
    <nct_id>NCT03255148</nct_id>
  </id_info>
  <brief_title>Influence of Oxytocin on Resting State Neurophysiological Measures</brief_title>
  <official_title>Influence of Oxytocin on Resting State Neurophysiological Measures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Research Foundation Flanders</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators will explore the influence of oxytocin administration on&#xD;
      several neurophysiological responses (EEG, skin conductance and heart rate) during rest.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oxytocin is known to influence several neurophysiological measures, such as heart rate, EEG&#xD;
      and skin conductance during specific tasks (e.g., emotion recognition, fear learning and&#xD;
      extinction). However, not much is known about the influence of oxytocin on those measures&#xD;
      during rest. Therefore, in this randomized, placebo controlled, double blinded study, the&#xD;
      investigators will investigate the influence of oxytocin during a resting period of 5&#xD;
      minutes. Heart rate, skin conductance, respiration and EEG will be measured before and after&#xD;
      oxytocin or placebo administration. The investigators expect that oxytocin will increase the&#xD;
      heart rate variability and decrease the skin conductance levels. Exploratory, the&#xD;
      investigators will conduct a cross-frequency analysis of band power and asses the&#xD;
      relationship between distinct indexes of sympathetic / parasympathetic balance.&#xD;
&#xD;
      Please note that this study is part of a larger study in which the investigators also asses&#xD;
      the influence of oxytocin on neurophysiological responses elicited by direct gaze&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">May 18, 2018</completion_date>
  <primary_completion_date type="Actual">May 18, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in heart rate variability after oxytocin administration</measure>
    <time_frame>Assessment over 5 minutes, before and after oxytocin or placebo administration</time_frame>
    <description>The influence of oxytocin administration on heart rate variability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in skin conductance level after oxytocin administration</measure>
    <time_frame>Assessment over 5 minutes, before and after oxytocin or placebo administration</time_frame>
    <description>The influence of oxytocin administration on skin conductance level</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Oxytocin</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Syntocinon nasal spray</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>syntocinon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo nasal spray</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  right-handed&#xD;
&#xD;
          -  male&#xD;
&#xD;
          -  age between 18 and 35&#xD;
&#xD;
          -  Normal or adjusted-to-normal vision (with lenses only)&#xD;
&#xD;
          -  Dutch as mother tongue&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not right-handed&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  age below 18 or above 35&#xD;
&#xD;
          -  Need to wear glasses&#xD;
&#xD;
          -  Dutch not as mother tongue&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaat Alaerts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KU Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>July 31, 2019</last_update_submitted>
  <last_update_submitted_qc>July 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Kaat Alaerts</investigator_full_name>
    <investigator_title>Prof. Dr. Kaat Alaerts</investigator_title>
  </responsible_party>
  <keyword>resting state</keyword>
  <keyword>EEG</keyword>
  <keyword>skin conductance</keyword>
  <keyword>heart rate</keyword>
  <keyword>oxytocin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03255148
org study id: SingleOT_REST_S56327
nct id: NCT03255148
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the investigators will explore the influence of oxytocin administration on
      several neurophysiological responses (EEG, skin conductance and heart rate) during rest.
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in heart rate variability after oxytocin administration
time frame: Assessment over 5 minutes, before and after oxytocin or placebo administration
description: The influence of oxytocin administration on heart rate variability
measure: Change in skin conductance level after oxytocin administration
time frame: Assessment over 5 minutes, before and after oxytocin or placebo administration
description: The influence of oxytocin administration on skin conductance level
arm group label: Oxytocin
arm group type: Experimental
description: 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)
arm group label: Placebo
arm group type: Placebo Comparator
description: saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)
intervention type: Drug
intervention name: Oxytocin
description: Syntocinon nasal spray
arm group label: Oxytocin
other name: syntocinon
intervention type: Drug
intervention name: Placebo
description: Placebo nasal spray
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kaat Alaerts, PhD
role: Principal Investigator
affiliation: KU Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Kaat Alaerts
investigator title: Prof. Dr. Kaat Alaerts
mesh term: Oxytocin