Clinical trial NCT07027410: Effect of Intermittent Normobaric Hypoxia on Executive Functions
Official title: Effect of Intermittent Normobaric Hypoxia on Executive Functions Assessed With Different Cognitive Tests in Healthy Young Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Executive Function (Cognition)
Normobaric Hypoxia
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Double Trouble Test
timeFrame: Day 1
measure: Monkey Ladder Test
timeFrame: Day 1
measure: Odd One Out Test
timeFrame: Day 1
Secondary outcomes:
measure: Blood Pressure
timeFrame: Day 1
measure: Oxygen Saturation
timeFrame: During intervention
measure: Heart Rate
timeFrame: During intervention
measure: Sociodemographic Questionnaire
timeFrame: Pre-test
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio de Murcia
state: Guadalupe
city: Murcia
country: Spain
facility: Universidad Católica San Antonio de Murcia
Study officials:
affiliation: Universidad Católica San Antonio de Murcia
name: Raquel Vaquero Cristóbal, PhD
role: PRINCIPAL_INVESTIGATOR
References: