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Changes in Aviators' Body Core Temperature Measurements at F-35

Primary Purpose

Aviation, Heat Stress

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Core temperature measurements
Sponsored by
Israeli Air Force Aeromedical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Aviation focused on measuring Heat stress, pilots

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • F35 pilots
  • Signing on informed consent

Exclusion Criteria:

  • Sickness two weeks prior the experiment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    F35 pilots

    F15 pilots

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mean core temp. of F35 pilots in hot weather conditions

    Secondary Outcome Measures

    Full Information

    First Posted
    July 26, 2017
    Last Updated
    July 26, 2017
    Sponsor
    Israeli Air Force Aeromedical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03234270
    Brief Title
    Changes in Aviators' Body Core Temperature Measurements at F-35
    Official Title
    Changes in Aviators' Body Core Temperature Measurements at F-35
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2017 (Anticipated)
    Primary Completion Date
    September 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Israeli Air Force Aeromedical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aviation, Heat Stress
    Keywords
    Heat stress, pilots

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    F35 pilots
    Arm Type
    Experimental
    Arm Title
    F15 pilots
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Core temperature measurements
    Intervention Description
    Core temperature measurements with coretemp pill
    Primary Outcome Measure Information:
    Title
    Mean core temp. of F35 pilots in hot weather conditions
    Time Frame
    40 minutes

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: F35 pilots Signing on informed consent Exclusion Criteria: Sickness two weeks prior the experiment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anna Levkovsky, BSc
    Phone
    +972-543149613
    Email
    anna.levkovsky@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Changes in Aviators' Body Core Temperature Measurements at F-35

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