<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/NCT03823677</url>
  </required_header>
  <id_info>
    <org_study_id>DRU-EMO-KOELN</org_study_id>
    <nct_id>NCT03823677</nct_id>
  </id_info>
  <brief_title>Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia</brief_title>
  <acronym>DRU-EMO-K</acronym>
  <official_title>Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Köln</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Köln</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>
      This study analyses both Protein Expression and emotional alterations during hypobaric&#xD;
      hypoxia in volunteers of different groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study analyses both Protein Expression and emotional alterations during hypobaric&#xD;
      hypoxia in volunteers of different groups.&#xD;
&#xD;
      15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group&#xD;
      and 15000ft Group - all for 15, 30, and 60 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">April 30, 2022</completion_date>
  <primary_completion_date type="Actual">April 30, 2022</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>Single Group Assignment</intervention_model>
    <intervention_model_description>15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group and 15000ft Group - all for 15, 30, and 60 minutes.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>volunteers</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Protein Expression before hypoxia</measure>
    <time_frame>Measurement immediately 1 minute before of hypoxia/experiment</time_frame>
    <description>proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Protein Expression after hypoxia</measure>
    <time_frame>Measurement immediately and at termination (i.e., 1 minute after) of hypoxia/experiment</time_frame>
    <description>proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional assessment tears</measure>
    <time_frame>Measurement starts immediately with hypoxia in the pressure chamber. duration 10 minutes</time_frame>
    <description>Emotional tears test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional assessment</measure>
    <time_frame>Measurement in the pressure chamber after tears test (i.e. 10 minutes after start). duration 10 minutes</time_frame>
    <description>Emotional stroop test; Williams, J. M. G., Mathews, A., &amp; MacLeod, C. (1996). The emotional Stroop task and psychopathology. Psychological Bulletin, 120, 3-24.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional assessment mood</measure>
    <time_frame>Measurement in the pressure chamber after stroop test (i.e. 20 minutes after start). duration 10 minutes</time_frame>
    <description>Emotional mood test, POMS mood score. Shukitt-Hale, B., Banderet, L.E., &amp; Lieberman, H.R. (1998). Elevation-dependent symptom, mood, and performance changes produced by exposure to hypobaric hypoxia, The International Journal of Aviation Psychology, 8, 319-334,</description>
  </primary_outcome>
  <number_of_arms>15</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Hypoxia, Altitude</condition>
  <arm_group>
    <arm_group_label>control group 15</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Protein expression and emotional test&#xD;
15 minutes normoxia&#xD;
Interventions:&#xD;
Blood drawing 1 Minute before and 1 Minute after the pressure chamber Phase for Proteomic profiling with 2D-gels&#xD;
Emotional tests (tears, stroop, mood) during the pressure chamber phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group 30</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>30 minutes normoxia&#xD;
Interventions:&#xD;
Blood drawing 1 Minute before and 1 Minute after the pressure chamber Phase for Proteomic profiling with 2D-gels&#xD;
Emotional tests (tears, stroop, mood) during the pressure chamber phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group 60</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>60 minutes normoxia&#xD;
Interventions:&#xD;
Blood drawing 1 Minute before and 1 Minute after the pressure chamber Phase for Proteomic profiling with 2D-gels&#xD;
Emotional tests (tears, stroop, mood) during the pressure chamber phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxia 5000ft group 15</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 15 minutes hypoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxia 5000ft group 30</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 30 minutes hypoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxia 5000ft group 60</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 60 minutes hypoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxia 8000ft group 15</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 15 minutes hypoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxia 8000ft group 30</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 30 minutes hypoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxia 8000ft group 60</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 60 minutes hypoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxia 10000ft group 15</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 15 minutes hypoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxia 10000ft group 30</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 30 minutes hypoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxia 10000ft group 60</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 60 minutes hypoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxia 15000ft group 15</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 15 minutes hypoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxia 15000ft group 30</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 30 minutes hypoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypoxia 15000ft group 60</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: 60 minutes hypoxia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hypoxia</intervention_name>
    <description>hypoxia</description>
    <arm_group_label>hypoxia 10000ft group 15</arm_group_label>
    <arm_group_label>hypoxia 10000ft group 30</arm_group_label>
    <arm_group_label>hypoxia 10000ft group 60</arm_group_label>
    <arm_group_label>hypoxia 15000ft group 15</arm_group_label>
    <arm_group_label>hypoxia 15000ft group 30</arm_group_label>
    <arm_group_label>hypoxia 15000ft group 60</arm_group_label>
    <arm_group_label>hypoxia 5000ft group 15</arm_group_label>
    <arm_group_label>hypoxia 5000ft group 30</arm_group_label>
    <arm_group_label>hypoxia 5000ft group 60</arm_group_label>
    <arm_group_label>hypoxia 8000ft group 15</arm_group_label>
    <arm_group_label>hypoxia 8000ft group 30</arm_group_label>
    <arm_group_label>hypoxia 8000ft group 60</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Helathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ear problems&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jochen Hinkelbein</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital of Cologne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Cologne</name>
      <address>
        <city>Cologne</city>
        <state>NRW</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsklinikum Köln</investigator_affiliation>
    <investigator_full_name>Jochen Hinkelbein</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Altitude Sickness</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <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/NCT03823677
org study id: DRU-EMO-KOELN
nct id: NCT03823677
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study analyses both Protein Expression and emotional alterations during hypobaric
      hypoxia in volunteers of different groups.
This study analyses both Protein Expression and emotional alterations during hypobaric
      hypoxia in volunteers of different groups.

      15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group
      and 15000ft Group - all for 15, 30, and 60 minutes.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: 15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group and 15000ft Group - all for 15, 30, and 60 minutes.
primary purpose: Diagnostic
masking: Single (Participant)
masking description: volunteers
measure: Protein Expression before hypoxia
time frame: Measurement immediately 1 minute before of hypoxia/experiment
description: proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics
measure: Protein Expression after hypoxia
time frame: Measurement immediately and at termination (i.e., 1 minute after) of hypoxia/experiment
description: proteomic profiling of Serum by 2D-gels. All Proteins present in the sample will be identified by proteomics
measure: Emotional assessment tears
time frame: Measurement starts immediately with hypoxia in the pressure chamber. duration 10 minutes
description: Emotional tears test
measure: Emotional assessment
time frame: Measurement in the pressure chamber after tears test (i.e. 10 minutes after start). duration 10 minutes
description: Emotional stroop test; Williams, J. M. G., Mathews, A., & MacLeod, C. (1996). The emotional Stroop task and psychopathology. Psychological Bulletin, 120, 3-24.
measure: Emotional assessment mood
time frame: Measurement in the pressure chamber after stroop test (i.e. 20 minutes after start). duration 10 minutes
description: Emotional mood test, POMS mood score. Shukitt-Hale, B., Banderet, L.E., & Lieberman, H.R. (1998). Elevation-dependent symptom, mood, and performance changes produced by exposure to hypobaric hypoxia, The International Journal of Aviation Psychology, 8, 319-334,
arm group label: control group 15
arm group type: No Intervention
description: Protein expression and emotional test
15 minutes normoxia
Interventions:
Blood drawing 1 Minute before and 1 Minute after the pressure chamber Phase for Proteomic profiling with 2D-gels
Emotional tests (tears, stroop, mood) during the pressure chamber phase
arm group label: control group 30
arm group type: No Intervention
description: 30 minutes normoxia
Interventions:
Blood drawing 1 Minute before and 1 Minute after the pressure chamber Phase for Proteomic profiling with 2D-gels
Emotional tests (tears, stroop, mood) during the pressure chamber phase
arm group label: control group 60
arm group type: No Intervention
description: 60 minutes normoxia
Interventions:
Blood drawing 1 Minute before and 1 Minute after the pressure chamber Phase for Proteomic profiling with 2D-gels
Emotional tests (tears, stroop, mood) during the pressure chamber phase
arm group label: hypoxia 5000ft group 15
arm group type: Experimental
description: Intervention: 15 minutes hypoxia
arm group label: hypoxia 5000ft group 30
arm group type: Experimental
description: Intervention: 30 minutes hypoxia
arm group label: hypoxia 5000ft group 60
arm group type: Experimental
description: Intervention: 60 minutes hypoxia
arm group label: hypoxia 8000ft group 15
arm group type: Experimental
description: Intervention: 15 minutes hypoxia
arm group label: hypoxia 8000ft group 30
arm group type: Experimental
description: Intervention: 30 minutes hypoxia
arm group label: hypoxia 8000ft group 60
arm group type: Experimental
description: Intervention: 60 minutes hypoxia
arm group label: hypoxia 10000ft group 15
arm group type: Experimental
description: Intervention: 15 minutes hypoxia
arm group label: hypoxia 10000ft group 30
arm group type: Experimental
description: Intervention: 30 minutes hypoxia
arm group label: hypoxia 10000ft group 60
arm group type: Experimental
description: Intervention: 60 minutes hypoxia
arm group label: hypoxia 15000ft group 15
arm group type: Experimental
description: Intervention: 15 minutes hypoxia
arm group label: hypoxia 15000ft group 30
arm group type: Experimental
description: Intervention: 30 minutes hypoxia
arm group label: hypoxia 15000ft group 60
arm group type: Experimental
description: Intervention: 60 minutes hypoxia
intervention type: Procedure
intervention name: Hypoxia
description: hypoxia
arm group label: hypoxia 10000ft group 15
arm group label: hypoxia 10000ft group 30
arm group label: hypoxia 10000ft group 60
arm group label: hypoxia 15000ft group 15
arm group label: hypoxia 15000ft group 30
arm group label: hypoxia 15000ft group 60
arm group label: hypoxia 5000ft group 15
arm group label: hypoxia 5000ft group 30
arm group label: hypoxia 5000ft group 60
arm group label: hypoxia 8000ft group 15
arm group label: hypoxia 8000ft group 30
arm group label: hypoxia 8000ft group 60
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jochen Hinkelbein
role: Study Chair
affiliation: University Hospital of Cologne
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Universitätsklinikum Köln
investigator full name: Jochen Hinkelbein
investigator title: Clinical Professor
mesh term: Altitude Sickness
mesh term: Hypoxia
sharing ipd: No