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CompletedNCT07027410Updated Jun 18, 2025

Effect of Intermittent Normobaric Hypoxia on Executive Functions

An interventional study of Intermittent normobaric hypoxia and Normoxia in Executive Function (Cognition) and Normobaric Hypoxia, sponsored by Universidad Católica San Antonio de Murcia. Completed at 2 sites in Spain. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by Universidad Católica San Antonio de Murcia · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Mar 2023, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Executive Function (Cognition)
  • Normobaric Hypoxia

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03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 27 is below the median of 45 across 853 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Universidad Católica San Antonio de Murcia is the lead sponsor of 132 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Young people aged between 18 and 40 years old

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Intermittent Hypoxia Group

    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.

    Device: Intermittent normobaric hypoxia

  • Other
    No Hypoxia Group

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

    Other: Normoxia

Interventions

  • DeviceIntermittent normobaric hypoxia

    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.

  • OtherNormoxia

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

06

What researchers measure

Primary outcomes

  1. Double Trouble Test

    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)

    Time frame: Day 1

  2. Monkey Ladder Test

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

    Time frame: Day 1

  3. Odd One Out Test

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

    Time frame: Day 1

Secondary outcomes

  1. Blood Pressure

    Average of systolic and diastolic blood pressure measured in mmHg

    Time frame: Day 1

  2. Oxygen Saturation

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

    Time frame: During intervention

  3. Heart Rate

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

    Time frame: During intervention

  4. Sociodemographic Questionnaire

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

    Time frame: Pre-test

07

Study locations

2 sites
  • Universidad Católica San Antonio de Murcia
    Murcia, Guadalupe 30107, Spain
  • Universidad Católica San Antonio de Murcia
    Murcia, Spain
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to ethical and privacy considerations.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07027410
Lead sponsor
Universidad Católica San Antonio de Murcia
Responsible party
Raquel Vaquero-Cristóbal (Principal Investigator, Universidad Católica San Antonio de Murcia) — Principal investigator
First posted
Jun 18, 2025
Start date
Mar 1, 2023
Primary completion
Apr 30, 2023
Completion
Dec 1, 2024
Last update
Jun 18, 2025

Study contacts

Raquel Vaquero Cristóbal, PhD
principal investigator · Universidad Católica San Antonio de Murcia

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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