NCT07027410

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

May 24, 2025

Last Update Submit

June 16, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

    Day 1

  • 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.

    Day 1

  • 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.

    Day 1

Secondary Outcomes (4)

  • Blood Pressure

    Day 1

  • Oxygen Saturation

    During intervention

  • Heart Rate

    During intervention

  • Sociodemographic Questionnaire

    Pre-test

Study Arms (2)

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.

Device: Intermittent normobaric hypoxia

No Hypoxia Group

OTHER

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

Other: Normoxia

Interventions

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.

Intermittent Hypoxia Group

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

No Hypoxia Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Young people aged between 18 and 40 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad Católica San Antonio de Murcia

Murcia, Guadalupe, 30107, Spain

Location

Universidad Católica San Antonio de Murcia

Murcia, Spain

Location

Study Officials

  • Raquel Vaquero Cristóbal, PhD

    Universidad Católica San Antonio de Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2025

First Posted

June 18, 2025

Study Start

March 1, 2023

Primary Completion

April 30, 2023

Study Completion

December 1, 2024

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical and privacy considerations.

Locations