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临床试验/NCT06017882
NCT06017882招募中不适用

Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload

Direction Centrale du Service de Santé des Armées1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
28
试验地点
1
主要终点
Difference in average tracking accuracy on the simulator MATB-II depending on centrifuge acceleration (quantitative measurement)

研究概览

简要总结

Fighter pilots have to perform tasks requiring high mental workload during moderate-intensity acceleration phases (2 to 3G) that can last several minutes. When these accelerations are performed in the body axis (+Gz), they induce a redistribution of blood flow in the lower limbs associated with a decrease in cerebral blood flow, partially compensated by activation of the sympathetic nervous system (baroreflex).

The main hypothesis is that the effects of these prolonged accelerations, even of moderate intensity (<+4Gz), could impair pilots' ability to perform complex cognitive tasks, with potential consequences for flight safety and mission conduct.

Moreover, flight missions are often performed after sleep debt, which is known to induce cardiovascular responses, sympathetic nervous system activation and impaired mental performance.

The secondary hypothesis is that sleep debt (3h of time spent in bed) may increase the impairment of cognitive performance during prolonged acceleration.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subject (male or female);
  • Tobacco consumption < 5 cigarettes per day or nicotine-free vapour;
  • Regular physical activity (between 1 and 8 hours per week);
  • Affiliated or entitled to a social security scheme;
  • Having given their consent.

排除标准

  • Presenting an active medical pathology or a history <6 months (cardiological, renal, hepatic, cutaneous, neurological, psychiatric...), or a significant deviation from normal values observed during questioning, clinical examination or electrocardiogram (ECG);
  • BMI > 30 (cardiovascular risk factor);
  • Have a medical contraindication to sporting activities;
  • Taking a medical treatment;
  • Habitual sleep duration < 6 hours;
  • Presenting a sleep disorder confirmed by questionnaire (Pittsburgh Sleep Quality Index Questionnaire > 5);
  • Pregnant or breastfeeding
  • Not covered by a health insurance plan;

结局指标

主要结局

Difference in average tracking accuracy on the simulator MATB-II depending on centrifuge acceleration (quantitative measurement)

时间窗: Through study completion (26 months)

MATB-II (Multi Attribute Task Battery) is a complex task simulator that mimics realistic tasks commonly performed by aircraft pilots during flight. Among these tasks, target tracking involves positioning a reticle at the center of the simulator's artificial horizon. The variance of the reticle's position as a function of the acceleration received in the centrifuge will be the primary outcome mesure in this study. This is a quantitative measure provided by the simulator.

次要结局

未报告次要终点

研究者

发起方
Direction Centrale du Service de Santé des Armées
申办方类型
Other
责任方
Sponsor

研究点 (1)

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