<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/NCT03234270</url>
  </required_header>
  <id_info>
    <org_study_id>Coretemp 1799-2017</org_study_id>
    <nct_id>NCT03234270</nct_id>
  </id_info>
  <brief_title>Changes in Aviators' Body Core Temperature Measurements at F-35</brief_title>
  <official_title>Changes in Aviators' Body Core Temperature Measurements at F-35</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Israeli Air Force Aeromedical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Israeli Air Force Aeromedical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 many complaints that have been expressed by the US aircrew of the F-35 regarding the heat&#xD;
      stress in the cockpit raised an obvious concern that, as a result of such heat levels, the&#xD;
      aviators' core body temperature may increase significantly, and subsequently cause severe&#xD;
      cognitive impairment- risking both the pilot and the mission.&#xD;
&#xD;
      In order to validate this hypothesis, we will measure the aviators' core body temperatures&#xD;
      while inside the cockpit of the F-35, to see whether their core body temperatures are rising&#xD;
      to a level that can cause heat stress or not. The temperatures will be measured on another&#xD;
      fourth generation aircraft as well for comparing purposes.&#xD;
&#xD;
      The temperatures will be measured using a Telemetric pill which will be ingested by each&#xD;
      aviator. Once ingested, the pill will transmit the data to an external monitor. The collected&#xD;
      data will be examined and analyzed in order to determine the likelihood of heat stress&#xD;
      occurrence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean core temp. of F35 pilots in hot weather conditions</measure>
    <time_frame>40 minutes</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Aviation</condition>
  <condition>Heat Stress</condition>
  <arm_group>
    <arm_group_label>F35 pilots</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>F15 pilots</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Core temperature measurements</intervention_name>
    <description>Core temperature measurements with coretemp pill</description>
    <arm_group_label>F15 pilots</arm_group_label>
    <arm_group_label>F35 pilots</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  F35 pilots&#xD;
&#xD;
          -  Signing on informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sickness two weeks prior the experiment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anna Levkovsky, BSc</last_name>
    <phone>+972-543149613</phone>
    <email>anna.levkovsky@gmail.com</email>
  </overall_contact>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heat stress, pilots</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heat Stress Disorders</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/NCT03234270
org study id: Coretemp 1799-2017
nct id: NCT03234270
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The many complaints that have been expressed by the US aircrew of the F-35 regarding the heat
      stress in the cockpit raised an obvious concern that, as a result of such heat levels, the
      aviators' core body temperature may increase significantly, and subsequently cause severe
      cognitive impairment- risking both the pilot and the mission.

      In order to validate this hypothesis, we will measure the aviators' core body temperatures
      while inside the cockpit of the F-35, to see whether their core body temperatures are rising
      to a level that can cause heat stress or not. The temperatures will be measured on another
      fourth generation aircraft as well for comparing purposes.

      The temperatures will be measured using a Telemetric pill which will be ingested by each
      aviator. Once ingested, the pill will transmit the data to an external monitor. The collected
      data will be examined and analyzed in order to determine the likelihood of heat stress
      occurrence.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Mean core temp. of F35 pilots in hot weather conditions
time frame: 40 minutes
arm group label: F35 pilots
arm group type: Experimental
arm group label: F15 pilots
arm group type: Active Comparator
intervention type: Device
intervention name: Core temperature measurements
description: Core temperature measurements with coretemp pill
arm group label: F15 pilots
arm group label: F35 pilots
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anna Levkovsky, BSc
phone: +972-543149613
email: anna.levkovsky@gmail.com
responsible party type: Sponsor
mesh term: Heat Stress Disorders
sharing ipd: No