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Completed

NCT Number: NCT07027410

Effect of Intermittent Normobaric Hypoxia on Executive Functions

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica San Antonio de Murcia, Murcia, Guadalupe, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Young people aged between 18 and 40 years old

Exclusion criteria

  • 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.

Treatment and study plan

Intermittent normobaric hypoxia

Device

Participants in the experimental group undergo a single session of intermittent normobaric hypoxia simulated by the iAltitude device. The session consists of breathing air with 12% oxygen concentration (equivalent to 4400 meters altitude) for a specified duration. Cognitive tests are administered before and after the hypoxia exposure to assess executive functions.

Normoxia

Other

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

Primary outcomes

  1. Double Trouble Test

    Time frame: 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)

  2. Monkey Ladder Test

    Time frame: 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.

  3. Odd One Out Test

    Time frame: 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.

Secondary outcomes

  1. Blood Pressure

    Time frame: Day 1

    Average of systolic and diastolic blood pressure measured in mmHg

  2. Oxygen Saturation

    Time frame: During intervention

    Oxygen saturation automatically monitored and recorded by the iAltitude hypoxia simulation system. Unit of Measure: %

  3. Heart Rate

    Time frame: During intervention

    Heart rate automatically monitored and recorded by the iAltitude hypoxia simulation system. Unit of Measure: Beats per minute (bpm)

  4. Sociodemographic Questionnaire

    Time frame: Pre-test

    To define individual characteristics of participants such as age and gender.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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