<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/NCT03303118</url>
  </required_header>
  <id_info>
    <org_study_id>2017-00752</org_study_id>
    <nct_id>NCT03303118</nct_id>
  </id_info>
  <brief_title>The Effects of Hypobaria vs Hypoxia on Cerebral Functions.</brief_title>
  <acronym>Hypoxia</acronym>
  <official_title>The Effects of Hypobaria vs Hypoxia on Cerebral Vasoreactivity, Brain's Electrical Activity and Concentration Performance on Pilots.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fliegerärztliches Institut</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fliegerärztliches Institut</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 investigators will investigate the effect of hypobaria and hypoxia on physiological&#xD;
      responses such as: oxygen saturation, heart rate, cerebral blood flow, cerebral oxygenation,&#xD;
      brain's activity and concentration performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main goal of this project is to investigate how hypoxia affects cognitive functions. The&#xD;
      KLT-R test asses the concentration level of a person. Subjects will do this test at different&#xD;
      simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Investigators'&#xD;
      first hypothesis is that concentration level will be altered by hypoxia. The higher altitude&#xD;
      the subjects are, the more the concentration would be altered. KLT-R performance would be&#xD;
      impaired by hypoxia compare to sea level performance.&#xD;
&#xD;
      The primary endpoint of this project is to investigate how KLT-R performance is affected by&#xD;
      the different hypoxic conditions. KLT-R test will be passed nine times in total during the&#xD;
      test visit. There will be a pre-test; a test at each of the conditions (3000m HH, 5500m HH,&#xD;
      5500m NH and 5500m HN); between each condition at sea level (to have a new baseline before&#xD;
      each condition) and a post-test at the end of the protocol. To avoid influence of fatigue,&#xD;
      all conditions will be randomized.&#xD;
&#xD;
      The second endpoint of this study is how the brain electrical activity is modulated by&#xD;
      hypoxia. Micro-states also will be measure during hypobaric hypoxia conditions (3000m HH and&#xD;
      5500m HH).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2017</start_date>
  <completion_date type="Actual">March 5, 2018</completion_date>
  <primary_completion_date type="Actual">March 5, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single-Blind study.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration performance</measure>
    <time_frame>4 minutes per test</time_frame>
    <description>Performance of concentration at different altitude levels.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EEG micro-states</measure>
    <time_frame>5 minutes per record</time_frame>
    <description>5 minutes recording in each conditions, eyes closed, at rest.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cerebral vaso-reactivity</measure>
    <time_frame>8 Minutes per test</time_frame>
    <description>Cerebral vasoreactivity after 1 minute hyperventilation and 3 minutes breathing of 5% CO2 mixture.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Cerebral Hypoxia</condition>
  <arm_group>
    <arm_group_label>Left</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No product administration will be done in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hypoxia</intervention_name>
    <description>No drug or product will be used in this study. No medication will be give to the participants. No arm will be used for product administration.</description>
    <arm_group_label>Left</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No history of flight sickness&#xD;
&#xD;
          -  No relevant medical diseases&#xD;
&#xD;
          -  Age 18 - 40 years&#xD;
&#xD;
          -  Written consent acceptance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pathologies&#xD;
&#xD;
          -  Relevant medical disorders&#xD;
&#xD;
          -  Drug addiction&#xD;
&#xD;
          -  Anemia or poor health&#xD;
&#xD;
          -  People who have already had problems with elevation&#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>Mathias Aebi</name>
      <address>
        <city>Dübendorf</city>
        <state>Zürich</state>
        <zip>8600</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fliegerärztliches Institut</investigator_affiliation>
    <investigator_full_name>Mathias Aebi, PhD</investigator_full_name>
    <investigator_title>Dr. med Denis Bron</investigator_title>
  </responsible_party>
  <keyword>Hypoxia</keyword>
  <keyword>Brain</keyword>
  <keyword>Cerebral vaso-reactivity</keyword>
  <keyword>EEG</keyword>
  <keyword>Concentration performance</keyword>
  <keyword>Cerebral oxygenation</keyword>
  <keyword>Cerebral blood-flow</keyword>
  <keyword>Heart rate variability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia, Brain</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Results will be shared in scientific publications by the end of this year and in 2018.</ipd_description>
  </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/NCT03303118
org study id: 2017-00752
nct id: NCT03303118
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will investigate the effect of hypobaria and hypoxia on physiological
      responses such as: oxygen saturation, heart rate, cerebral blood flow, cerebral oxygenation,
      brain's activity and concentration performance.
The main goal of this project is to investigate how hypoxia affects cognitive functions. The
      KLT-R test asses the concentration level of a person. Subjects will do this test at different
      simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Investigators'
      first hypothesis is that concentration level will be altered by hypoxia. The higher altitude
      the subjects are, the more the concentration would be altered. KLT-R performance would be
      impaired by hypoxia compare to sea level performance.

      The primary endpoint of this project is to investigate how KLT-R performance is affected by
      the different hypoxic conditions. KLT-R test will be passed nine times in total during the
      test visit. There will be a pre-test; a test at each of the conditions (3000m HH, 5500m HH,
      5500m NH and 5500m HN); between each condition at sea level (to have a new baseline before
      each condition) and a post-test at the end of the protocol. To avoid influence of fatigue,
      all conditions will be randomized.

      The second endpoint of this study is how the brain electrical activity is modulated by
      hypoxia. Micro-states also will be measure during hypobaric hypoxia conditions (3000m HH and
      5500m HH).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single-Blind study.
primary purpose: Other
masking: None (Open Label)
measure: Concentration performance
time frame: 4 minutes per test
description: Performance of concentration at different altitude levels.
measure: EEG micro-states
time frame: 5 minutes per record
description: 5 minutes recording in each conditions, eyes closed, at rest.
measure: Cerebral vaso-reactivity
time frame: 8 Minutes per test
description: Cerebral vasoreactivity after 1 minute hyperventilation and 3 minutes breathing of 5% CO2 mixture.
arm group label: Left
arm group type: Other
description: No product administration will be done in this study.
intervention type: Other
intervention name: Hypoxia
description: No drug or product will be used in this study. No medication will be give to the participants. No arm will be used for product administration.
arm group label: Left
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Fliegerärztliches Institut
investigator full name: Mathias Aebi, PhD
investigator title: Dr. med Denis Bron
mesh term: Hypoxia, Brain
mesh term: Hypoxia
sharing ipd: No
ipd description: Results will be shared in scientific publications by the end of this year and in 2018.