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Effect of Intermittent Normobaric Hypoxia on Executive Functions

U

Universidad Católica San Antonio de Murcia

Status

Completed

Conditions

Executive Function (Cognition)
Normobaric Hypoxia

Treatments

Other: Normoxia
Device: Intermittent normobaric hypoxia

Study type

Interventional

Funder types

Other

Identifiers

NCT07027410
4145/2022

Details and patient eligibility

About

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.

Full description

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.

Enrollment

27 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

27 participants in 2 patient groups

Intermittent Hypoxia Group
Experimental group
Description:
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.
Treatment:
Device: Intermittent normobaric hypoxia
No Hypoxia Group
Other group
Description:
Participants undergo the same cognitive tests without exposure to hypoxia, serving as the control condition.
Treatment:
Other: Normoxia

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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