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

Heat Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03234270
• Other study ID #: Coretemp 1799-2017
• Status: Not yet recruiting
• Phase: N/A
• First received: July 26, 2017
• Last updated: July 26, 2017
• Start date: July 2017
• Est. completion date: December 2017

Study information

• Verified date: July 2017
• Source: Israeli Air Force Aeromedical Center
• Contact: Anna Levkovsky, BSc
• Phone: +972-543149613
• Email: anna.levkovsky[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• F35 pilots

• Signing on informed consent

Exclusion Criteria:

• Sickness two weeks prior the experiment

Related Conditions & MeSH terms

• Aviation
• Heat Stress
• Heat Stress Disorders

Intervention

Device:
• Core temperature measurements
Core temperature measurements with coretemp pill

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Israeli Air Force Aeromedical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean core temp. of F35 pilots in hot weather conditions		40 minutes