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临床试验/NCT07027410
NCT07027410已完成不适用

Effect of Intermittent Normobaric Hypoxia on Executive Functions Assessed With Different Cognitive Tests in Healthy Young Subjects

Universidad Católica San Antonio de Murcia2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
2
主要终点
Double Trouble Test

研究概览

简要总结

The main objective of this study was to analyze the effects of an intermittent normobaric hypoxia session on executive functions assessed with different cognitive tests given to healthy young subjects. Twenty-seven healthy volunteers were divided into an experimental group (EG; n=13) and a control group (CG; n=14). The EG performed the 'Odd One Out', 'Double Trouble' and 'Monkey Ladder' tests before and after the hypoxia tolerance session (12%, 4400 m) with the iAltitude simulator. The CG completed the same tests without hypoxia exposure.

详细描述

The main objective of this study will be to analyze the effects of an intermittent normobaric hypoxia session on executive functions, assessed using different cognitive tests administered to healthy young subjects. A total of 27 healthy volunteers will be divided into two groups: an experimental group (EG; n=13) and a control group (CG; n=14).

The experimental group will perform the 'Odd One Out', 'Double Trouble', and 'Monkey Ladder' tests immediately before and after a hypoxia tolerance session (12% oxygen, equivalent to 4400 meters) using the iAltitude simulator. The control group will complete the same tests under normoxic conditions, without exposure to hypoxia.

The primary outcomes will include changes in cognitive performance scores in the administered tests. The experimental group is expected to show improvements in the Double Trouble test scores following hypoxia exposure. The control group may also show changes in the Double Trouble and Odd One Out tests between the pre- and post-tests.

Secondary outcomes will include physiological variables such as oxygen saturation (SaO₂) and heart rate (HR), which will be monitored during the hypoxia session in the EG. Statistically significant changes in SaO₂ and HR are anticipated as a result of the hypoxic exposure.

This study aims to determine whether a single session of intermittent normobaric hypoxia can lead to selective improvements in executive functions, particularly sustained attention, without negatively affecting other cognitive domains.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Young people aged between 18 and 40 years old

排除标准

  • •Pregnancy
  • •Prior experience in hypoxia training
  • •Previous experience in executive function tests
  • •Personal or family history of cardiovascular diseases or chronic conditions
  • •Diagnosed cardiac disorders.

研究组 & 干预措施

Intermittent Hypoxia Group

Experimental

Participants are exposed to a single session of intermittent normobaric hypoxia at 12% oxygen concentration (equivalent to 4400 m altitude) using the iAltitude simulator. Cognitive tests are performed before and after the hypoxia session.

干预措施: Intermittent normobaric hypoxia (Device)

No Hypoxia Group

Other

Participants undergo the same cognitive tests without exposure to hypoxia, serving as the control condition.

干预措施: Normoxia (Other)

结局指标

主要结局

Double Trouble Test

时间窗: Day 1

Change in cognitive performance score on the Double Trouble test; higher scores indicate better executive function and attention control. Unit of Measure: Score (units on a scale)

Monkey Ladder Test

时间窗: Day 1

Change in cognitive performance score on the Monkey Ladder test; higher scores indicate better visuospatial working memory. Unit of Measure: Score and Level.

Odd One Out Test

时间窗: Day 1

Change in reasoning performance score on the Odd One Out test; higher scores indicate better problem-solving ability. Unit of Measure: Score and Level.

次要结局

  • Blood Pressure(Day 1)
  • Oxygen Saturation(During intervention)
  • Heart Rate(During intervention)
  • Sociodemographic Questionnaire(Pre-test)

研究者

发起方
Universidad Católica San Antonio de Murcia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raquel Vaquero-Cristóbal

Principal Investigator

Universidad Católica San Antonio de Murcia

研究点 (2)

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