<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/NCT03227081</url>
  </required_header>
  <id_info>
    <org_study_id>SK 062016_rev</org_study_id>
    <nct_id>NCT03227081</nct_id>
  </id_info>
  <brief_title>Behavioral Modulation of Intrusive Memories</brief_title>
  <official_title>Behavioral Modulation of Memory Traces: Influence of Sleep on Emotional Regulation and the Consolidation of Intrusive Memories</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</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>
      The purpose of the study is to examine whether sleep affects the development of intrusive&#xD;
      memories.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Actual">February 4, 2020</completion_date>
  <primary_completion_date type="Actual">February 4, 2020</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intrusive memories</measure>
    <time_frame>seven consecutive days</time_frame>
    <description>Intrusive memories measured with an intrusion diary</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Intrusive Memories</condition>
  <arm_group>
    <arm_group_label>Sleep</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Sleep</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep Deprivation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sleep Deprivation</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Deprivation</intervention_name>
    <description>Sleep Deprivation</description>
    <arm_group_label>Sleep Deprivation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy participants&#xD;
&#xD;
          -  German on a native level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  former or present psychiatric disorders&#xD;
&#xD;
          -  physical illnesses&#xD;
&#xD;
          -  history of trauma&#xD;
&#xD;
          -  pregnancy or lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dr. Dimitris Repantis</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Dimitris Repantis</investigator_full_name>
    <investigator_title>Dr. med.</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03227081
org study id: SK 062016_rev
nct id: NCT03227081
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to examine whether sleep affects the development of intrusive
      memories.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Intrusive memories
time frame: seven consecutive days
description: Intrusive memories measured with an intrusion diary
arm group label: Sleep
arm group type: No Intervention
description: Sleep
arm group label: Sleep Deprivation
arm group type: Experimental
description: Sleep Deprivation
intervention type: Behavioral
intervention name: Sleep Deprivation
description: Sleep Deprivation
arm group label: Sleep Deprivation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Dimitris Repantis
investigator title: Dr. med.
sharing ipd: No