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临床试验/NCT05563688
NCT05563688招募中不适用

Effect of Acute Sleep Restriction on Responses to Hypoxia

Direction Centrale du Service de Santé des Armées1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年10月26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
25
试验地点
1
主要终点
Mean reaction time (in ms) to the 10-minute psychomotor vigilance task (PVT-10), at the end of the exposure.

研究概览

简要总结

At altitude, humans are exposed to environmental hypoxia induced by the decrease in barometric pressure. On duty or in training, mountain troops, paratroopers or aircrew are regularly exposed to altitude. The effects of altitude on humans occur gradually from 1500 m and depend on both the duration of exposure and the altitude level. Cognitive disorders can occur from 3500 m (threshold of disorders) but there is a very large inter-individual variability.

The countermeasure to altitude hypoxia is oxygen but its use is not systematic between 3000 and 4000 m. Its use depends on the duration of exposure, without clearly established standards. Incapacitating effects on the operational capacity and health of soldiers can therefore occur as early as 3500 m.

In operations or during training, altitude exposure is often associated with a significant sleep debt (particularly during night or early morning missions), jet lag or precarious rest conditions in overseas operations. These sleep restrictions promote the degradation of mental performance with effects similar to those observed in hypoxia.

The combination of these constraints induces a physiological stress which can favour alterations in mental performance, an increase in incapacity, intolerance to altitude or the occurrence of altitude-related pathologies in military personnel. This could occur in particular in the operational zone around the threshold of disorders (3500 m) where the indication of oxygen is discussed.

The objective of this study is to assess the impact of acute sleep restriction on hypoxia tolerance.

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
Male
接受健康志愿者

入选标准

  • Between 18 and 45
  • Smoking < 5 cigarettes per day or nicotine-free electronic cigarette
  • Having regular physical activity (between 1 and 4 hours of physical activity per week)
  • Affiliated or entitled to a social security plan
  • No contraindication to physical exercise
  • Having given their consent

排除标准

  • BMI > 30
  • Active medical pathology (cardiological, renal, hepatic, cutaneous, neurological, etc.),
  • History of active pathology of less than 6 months
  • Significant deviation with the normal values observed during the interrogation, clinical examination or electrocardiogram
  • Having spent time at altitude (> 3500 m) during the last 3 months
  • Absolute or relative contraindication to a stay at high altitude
  • Medical contraindication to sport practice
  • Skin allergy to modified ethanol or capsaicin
  • Wearing a pacemaker or ferromagnetic implants
  • Poor venous capital
  • Pittsburgh Sleep Quality Index Questionnaire > 5
  • Usual sleep duration < 6 hours
  • Not covered by a health insurance plan

结局指标

主要结局

Mean reaction time (in ms) to the 10-minute psychomotor vigilance task (PVT-10), at the end of the exposure.

时间窗: Through study completion (20.5 months)

PVT-10 is a sustained-attention, reaction-timed task that measures the consistency with which subjects respond to a visual stimulus. The participant sits in front of a computer. He has a screen in front of him with a 4-digit counter (0 at the start). He is instructed to click the left mouse button as fast as possible when the counter starts to scroll. The counter returns to zero when the participant has clicked. Reaction time (in ms) is calculated for each stimulus.

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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