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
About this trial
This is an interventional screening trial for Aviation focused on measuring Heat stress, pilots
Eligibility Criteria
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
NCT ID
NCT03234270
First Posted
July 26, 2017
Last Updated
July 26, 2017
Sponsor
Israeli Air Force Aeromedical Center
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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