Executive Function (Cognition)NCT07027410
Effect of Intermittent Normobaric Hypoxia on Executive Functions
A study testing Intermittent normobaric hypoxia and Normoxia in people with Executive Function (Cognition) and Normobaric Hypoxia, run by Universidad Católica San Antonio de Murcia at 2 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Function (Cognition), Normobaric Hypoxia
- What is being tested?
- Intermittent normobaric hypoxia and Normoxia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Mar 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young people aged between 18 and 40 years old
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Spain2 sites
Universidad Católica San Antonio de Murcia
Murcia, Guadalupe, 30107
Universidad Católica San Antonio de Murcia
Murcia
About this study
Official title: Effect of Intermittent Normobaric Hypoxia on Executive Functions Assessed With Different Cognitive Tests in Healthy Young Subjects
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.
- Conditions
- Executive Function (Cognition), Normobaric Hypoxia
- Being tested
- Intermittent normobaric hypoxia, Normoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent normobaric hypoxiaDevice
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.
NormoxiaOther
Participants undergo the same cognitive tests without exposure to hypoxia, serving as the control condition.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Intermittent normobaric hypoxia |
| No Hypoxia Group | Other | Participants undergo the same cognitive tests without exposure to hypoxia, serving as the control condition. Receives: Other: Normoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: Day 1
Secondary outcomes (4)
Blood Pressure
Average of systolic and diastolic blood pressure measured in mmHg
Measured: Day 1
Oxygen Saturation
Oxygen saturation automatically monitored and recorded by the iAltitude hypoxia simulation system. Unit of Measure: %
Measured: During intervention
Heart Rate
Heart rate automatically monitored and recorded by the iAltitude hypoxia simulation system. Unit of Measure: Beats per minute (bpm)
Measured: During intervention
Sociodemographic Questionnaire
To define individual characteristics of participants such as age and gender.
Measured: Pre-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Mar 2023
- Primary completion30 Apr 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive Function (Cognition)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Vaquero-Cristóbal, Universidad Católica San Antonio de Murcia
- Investigators
- Raquel Vaquero Cristóbal, PhD, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027410
- Sponsor's protocol ID
- 4145/2022
- Status last verified
- Jun 2025
- First submitted
- 24 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Normobaric Hypoxia on Executive Functions Assessed With Different Cognitive Tests in Healthy Young Subjects
- ClinicalTrials.gov ID
- NCT07027410
- Acronym / sponsor ID
- 4145/2022
- Conditions
- Executive Function (Cognition), Normobaric Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Hypoxia Group | Experimental | Device: Intermittent normobaric hypoxiaParticipants 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. |
| No Hypoxia Group | Other | Other: NormoxiaParticipants undergo the same cognitive tests without exposure to hypoxia, serving as the control condition. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young people aged between 18 and 40 years old
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent normobaric hypoxiaParticipants 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. | Device | Intermittent Hypoxia Group |
| NormoxiaParticipants undergo the same cognitive tests without exposure to hypoxia, serving as the control condition. | Other | No Hypoxia Group |
Primary outcome
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)
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.
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.
4 secondary outcomes
Blood Pressure
Time frame: Day 1
Oxygen Saturation
Time frame: During intervention
Heart Rate
Time frame: During intervention
Sociodemographic Questionnaire
Time frame: Pre-test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel Vaquero Cristóbal, PhD principal investigator
Universidad Católica San Antonio de Murcia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent normobaric hypoxia and Normoxia in people with Executive Function (Cognition) and Normobaric Hypoxia, run by Universidad Católica San Antonio de Murcia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Double Trouble Test (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.