Exertional Heat InjuryNCT06764264
Integrating Cognitive Assessments Into the Heat Tolerance Test After Exertional Heat Injury
An observational study of Exertional Heat Injury, run by Medical Corps, Israel Defense Force at 1 site in Israel.
Trial summary
This prospective observational study is to evaluate soldiers post-exertional heat injury (EHI) during a heat tolerant test (HTT) to investigate the impact on their cognitive performance. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Exertional Heat Injury
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2018to 21 Dec 2024
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Israeli Defense Forces combat soldiers
Who may be able to join
- Combat soldiers post exertional heat injury
Who cannot join
- Additional medical condition restricting combat duty
Trial locations and contacts
1 site in 1 country.
Israel1 site
Heller Institute, Institute of Military Physiology, IDF Medical Corps
Tel HaShomer, Israel
About this study
Official title: Cognitive Assessment During Heat Tolerance Test
This prospective observational study is to evaluate soldiers post-exertional heat injury (EHI) during a heat tolerant test (HTT) to investigate the impact on their cognitive performance.
Read the detailed description
The objective of the proposed research is to add a cognitive evaluation to the physiological parameters monitored in the heat tolerance test (HTT) and to construct a new cognitive-physiological model for evaluation based on the accumulated knowledge on soldiers' heat tolerance. Each year, in the Israel Defense Forces (IDF), approximately 50 soldiers post exertional heat injury (EHI) are referred to perform the HTT. The HTT is carried out approximately one month post injury as part of clinical evaluation of the patient and is also intended to determine return to duty for combatants in field units. Currently, the criteria used in the HTT to determine heat tolerance are based solely on physiological parameters, while no cognitive evaluation is utilized in the HTT. Noteworthy are the numerous studies published in scientific literature describing the influence of exposure to heat conditions and physical effort on cognition and psychological strain in humans.
The subjects performing the HTT will also undergo cognitive evaluation and psychological strain assessment using tests used and validated in the research laboratories of the United States military (USARIEM). The cognitive evaluation will be performed in addition to the validated physiological monitoring performed in the HTT. All gathered physiological and cognitive data will be used to construct new bio-statistical models and new criteria will be suggested for the definition of heat tolerance or intolerance.
- Conditions
- Exertional Heat Injury
- Keywords
- Heat Tolerance Test, Exertional heat injury, Cognitive Impairment, Thermoregulatory Function
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Combat soldiers post exertional heat injury | Participants were classified into heat-intolerant (HI) or heat-tolerant (HT) groups based on their HTT physiological outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Classified as Heat-Intolerant during Heat Tolerant Test
Participants are classified as heat-intolerant if they exhibit any of the following indicators during the Heat Tolerance Test: a core body temperature (Tre) ≥ 38.5°C (≥ 101.38°F), a heart rate (HR) ≥ 150 bpm, or failure to achieve a Tre-to-HR ratio ≥ 0.2798°C ∙ bpm-¹. Participants meeting none of these criteria are classified as heat-tolerant.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Feb 2018
- Primary completion21 Dec 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Exertional Heat InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Collaborators
- The Chaim Sheba Medical Center
- Responsible party
- Principal investigator, ITAY, Medical Corps, Israel Defense Force
- Investigators
- Daniel S Moran, PhD, Study director, Institute of Military Physiology, IDF Medical Corps, Tel Hashomer, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764264
- Sponsor's protocol ID
- IDF- 123 1779-2017
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data for this belong to the Israel Defense Forces and the Israel Ministry of Defense. Data sharing will be considered if the corresponding author receives a reasonable request and establishes an institution-to-institution data-sharing agreement.
Publications
Moran DS, Shitzer A, Pandolf KB. A physiological strain index to evaluate heat stress. Am J Physiol. 1998 Jul;275(1):R129-34. doi: 10.1152/ajpregu.1998.275.1.R129.
PubMed 9688970Epstein Y, Sohar E, Shapiro Y. Exertional heatstroke: a preventable condition. Isr J Med Sci. 1995 Jul;31(7):454-62.
PubMed 7607879Moran DS, Heled Y, Still L, Laor A, Shapiro Y. Assessment of heat tolerance for post exertional heat stroke individuals. Med Sci Monit. 2004 Jun;10(6):CR252-7. Epub 2004 Jun 1.
PubMed 15173669Moran DS, Erlich T, Epstein Y. The heat tolerance test: an efficient screening tool for evaluating susceptibility to heat. J Sport Rehabil. 2007 Aug;16(3):215-21. doi: 10.1123/jsr.16.3.215.
PubMed 17923727
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Assessment During Heat Tolerance Test
- ClinicalTrials.gov ID
- NCT06764264
- Acronym / sponsor ID
- IDF- 123 1779-2017
- Conditions
- Exertional Heat Injury
- Keywords
- Heat Tolerance Test, Exertional heat injury, Cognitive Impairment, Thermoregulatory Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Collaborators
- The Chaim Sheba Medical Center
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 8 Jan 2025 (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.
This prospective observational study is to evaluate soldiers post-exertional heat injury (EHI) during a heat tolerant test (HTT) to investigate the impact on their cognitive performance.
Detailed description
The objective of the proposed research is to add a cognitive evaluation to the physiological parameters monitored in the heat tolerance test (HTT) and to construct a new cognitive-physiological model for evaluation based on the accumulated knowledge on soldiers' heat tolerance. Each year, in the Israel Defense Forces (IDF), approximately 50 soldiers post exertional heat injury (EHI) are referred to perform the HTT. The HTT is carried out approximately one month post injury as part of clinical evaluation of the patient and is also intended to determine return to duty for combatants in field units. Currently, the criteria used in the HTT to determine heat tolerance are based solely on physiological parameters, while no cognitive evaluation is utilized in the HTT. Noteworthy are the numerous studies published in scientific literature describing the influence of exposure to heat conditions and physical effort on cognition and psychological strain in humans.
The subjects performing the HTT will also undergo cognitive evaluation and psychological strain assessment using tests used and validated in the research laboratories of the United States military (USARIEM). The cognitive evaluation will be performed in addition to the validated physiological monitoring performed in the HTT. All gathered physiological and cognitive data will be used to construct new bio-statistical models and new criteria will be suggested for the definition of heat tolerance or intolerance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combat soldiers post exertional heat injury | – | –Participants were classified into heat-intolerant (HI) or heat-tolerant (HT) groups based on their HTT physiological outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Israeli Defense Forces combat soldiers
Key inclusion criteria (1 listed)
- Combat soldiers post exertional heat injury
Key exclusion criteria (1 listed)
- Additional medical condition restricting combat duty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Classified as Heat-Intolerant during Heat Tolerant Test
Time frame: 120 minutes
Participants are classified as heat-intolerant if they exhibit any of the following indicators during the Heat Tolerance Test: a core body temperature (Tre) ≥ 38.5°C (≥ 101.38°F), a heart rate (HR) ≥ 150 bpm, or failure to achieve a Tre-to-HR ratio ≥ 0.2798°C ∙ bpm-¹. Participants meeting none of these criteria are classified as heat-tolerant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Results publication: PubMed 9688970Moran DS, Shitzer A, Pandolf KB. A physiological strain index to evaluate heat stress. Am J Physiol. 1998 Jul;275(1):R129-34. doi: 10.1152/ajpregu.1998.275.1.R129.
- Results publication: PubMed 7607879Epstein Y, Sohar E, Shapiro Y. Exertional heatstroke: a preventable condition. Isr J Med Sci. 1995 Jul;31(7):454-62.
- Results publication: PubMed 15173669Moran DS, Heled Y, Still L, Laor A, Shapiro Y. Assessment of heat tolerance for post exertional heat stroke individuals. Med Sci Monit. 2004 Jun;10(6):CR252-7. Epub 2004 Jun 1.
- Results publication: PubMed 17923727Moran DS, Erlich T, Epstein Y. The heat tolerance test: an efficient screening tool for evaluating susceptibility to heat. J Sport Rehabil. 2007 Aug;16(3):215-21. doi: 10.1123/jsr.16.3.215.
- Individual participant dataSharing planned: Yes. The data for this belong to the Israel Defense Forces and the Israel Ministry of Defense. Data sharing will be considered if the corresponding author receives a reasonable request and establishes an institution-to-institution data-sharing agreement.
Related trials for Exertional Heat Injury
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Active, not recruitingObservational study
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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.
Daniel S Moran, PhD study director
Institute of Military Physiology, IDF Medical Corps, Tel Hashomer, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exertional Heat Injury, run by Medical Corps, Israel Defense Force at 1 site in Israel.
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 1 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: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Classified as Heat-Intolerant during Heat Tolerant Test (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06764264, which also lists 4 linked publications.
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 8 Jan 2025.