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临床试验/NCT05100667
NCT05100667Unknown不适用

A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance

Vrije Universiteit Brussel3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
3
主要终点
Cerebral oxygenation

研究概览

简要总结

Introduction Both Mental Fatigue (MF) and hypoxia impair multiple aspects of cognitive functioning. The decline in cognitive functioning in hypoxic conditions is associated with alterations in brain oxygenation and hemodynamic responses. These hemodynamic responses are preferably measured at the prefrontal cortex, an area of the brain that is known for its executive function and role in decision making, planning, attention and (short-term) memory. This study will investigate the role of prefrontal cortex oxygenation during the development of mental fatigue and during cognitive performances by altering the ambient oxygen availability through normobaric hypoxia (3800m; 12,9% O2) and normoxia.

Methods Subjects will perform four trials in a sound-insulated climate chamber (20°C and 40% RH). Upon entry in the climatic chamber participants will adapt to the environment for 30 minutes. Next, they will perform a modified cognitive test battery "cognition", a fine motor task "Motor Performance Series" and a visuomotor-fitlight task before and after a 60-minute individualized Stroop task or control task (randomized. blinded, placebo controlled, counter-balanced, cross-over design). Nearinfrared spectroscopy (NIRS) will be used to assess hemodynamic changes (oxygenated hemoglobin (O2Hb), deoxygenated-hemoglobin (HHb) and total hemoglobin (tHb)) at the PFC.

Hypotheses 1) MF will lead to earlier changes in the prefrontal NIRS-parameters (O2Hb, HHb, tHb) with lower oxygen availability. 2) The effects of MF on cognitive performance manifest itself to a greater extent with lower oxygen availability.3) Visuomotor performance declines to a greater extent due to MF with lower oxygen availability.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

We will inform the participants in a way that explains the study as an investigation about the influence of different cognitive tasks on a subsequent physical task at various altitudes looking at other physiological outcome measures.

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 (No neurological or cardiovascular disorders)
  • Male or female
  • No medication
  • Non-smoker
  • Between 18 and 35 years old
  • Recreational athlete population; performance level 2 or 3 for men according to De Pauw et al. (2013)[29] and performance level 2 or 3 for woman according to Decroix et al. (2015)
  • Non-acclimatized to altitude (at least 2 months)

排除标准

  • Acclimated to altitude
  • Use of medication
  • Use of caffeine and heavy efforts 24 hours prior each trial
  • Not eating a standardized meal, the morning of each trial

结局指标

主要结局

Cerebral oxygenation

时间窗: 2 hours

Prefrontal cortex oxygenation = relative changes in oxy- and deoxy hemoglobin at the prefrontal cortex. During the whole frame, participants are equipped with a Near Infrared Spectroscopy device that measures cerebral oxygenation continuously at 10hz.

Mental fatigue

时间窗: 60 minutes

Results of a visual analogue scale for mental fatigue

次要结局

  • Fine motor control(5 minutes)
  • Visuomotor control(7 minutes)
  • Cognition(20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Romain Meeusen

Principal investigator

Vrije Universiteit Brussel

研究点 (3)

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