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临床试验/NCT06764264
NCT06764264已完成不适用

Cognitive Assessment During Heat Tolerance Test

Medical Corps, Israel Defense Force1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Number of Participants Classified as Heat-Intolerant during Heat Tolerant Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Combat soldiers post exertional heat injury

排除标准

  • Additional medical condition restricting combat duty

结局指标

主要结局

Number of Participants Classified as Heat-Intolerant during Heat Tolerant Test

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Medical Corps, Israel Defense Force
申办方类型
Other
责任方
Principal Investigator
主要研究者

ITAY

Dr. Sagi Shpitzer, MD, Chief Medical Officer, IDF Physiology Institute, Principal Investigator

Medical Corps, Israel Defense Force

研究点 (1)

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