AviationNCT03234270
Changes in Aviators' Body Core Temperature Measurements at F-35
A study testing Core temperature measurements in people with Aviation and Heat Stress, run by Israeli Air Force Aeromedical Center.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aviation, Heat Stress
- What is being tested?
- Core temperature measurements
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- F35 pilots
- Signing on informed consent
Who cannot join
- Sickness two weeks prior the experiment
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Aviation, Heat Stress
- Being tested
- Core temperature measurements
- Keywords
- Heat stress, pilots
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core temperature measurementsDevice
Core temperature measurements with coretemp pill
| Study group | Role | What they receive |
|---|---|---|
| F35 pilots | Experimental | Not described Receives: Device: Core temperature measurements |
| F15 pilots | Active comparator | Not described Receives: Device: Core temperature measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean core temp. of F35 pilots in hot weather conditions
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study startJul 2017 (estimated)
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AviationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Israeli Air Force Aeromedical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234270
- Sponsor's protocol ID
- Coretemp 1799-2017
- Status last verified
- Jul 2017
- First submitted
- 26 Jul 2017
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Aviators' Body Core Temperature Measurements at F-35
- ClinicalTrials.gov ID
- NCT03234270
- Acronym / sponsor ID
- Coretemp 1799-2017
- Conditions
- Aviation, Heat Stress
- Keywords
- Heat stress, pilots
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Israeli Air Force Aeromedical CenterOther government
- Study start
- Jul 2017 (estimated)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F35 pilots | Experimental | Device: Core temperature measurements |
| F15 pilots | Active comparator | Device: Core temperature measurements |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- F35 pilots
- Signing on informed consent
Key exclusion criteria (1 listed)
- Sickness two weeks prior the experiment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core temperature measurementsCore temperature measurements with coretemp pill | Device | F15 pilots, F35 pilots |
Primary outcome
Mean core temp. of F35 pilots in hot weather conditions
Time frame: 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Core temperature measurements in people with Aviation and Heat Stress, run by Israeli Air Force Aeromedical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Levkovsky, BSc (+972-543149613, anna.levkovsky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean core temp. of F35 pilots in hot weather conditions (time frame: 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.