NCT03234270

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

July 26, 2017

Last Update Submit

July 26, 2017

Conditions

Keywords

Heat stress, pilots

Outcome Measures

Primary Outcomes (1)

  • Mean core temp. of F35 pilots in hot weather conditions

    40 minutes

Study Arms (2)

F35 pilots

EXPERIMENTAL
Device: Core temperature measurements

F15 pilots

ACTIVE COMPARATOR
Device: Core temperature measurements

Interventions

Core temperature measurements with coretemp pill

F15 pilotsF35 pilots

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • F35 pilots
  • Signing on informed consent

You may not qualify if:

  • Sickness two weeks prior the experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heat Stress Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Anna Levkovsky, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 31, 2017

Study Start

July 1, 2017

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

July 31, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share