HypoxiaHYPCOGNCT06318312
Effects of Hypoxia on Cognitive Performance
A study testing Hypoxia in people with Hypoxia, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The goal of this clinical trial is to determine the effects of different hypoxia exposures (FiO2 = 11%, 13%, 15%, and 21%) on cognitive performance in healthy adults. The main questions it aims to answer are: What is the best hypoxia exposure to improve reaction time, anticipation, attention and memory tasks? Which… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Hypoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2024to 26 Apr 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active individuals ( >150 min/week moderate physical activity or >75 min/week vigorous physical activity)
- Non-smokers
- Individuals without serious and undiagnosed health problems
Who cannot join
- Pregnancy and/or breastfeeding
- Residing at an altitude of more than 1300 m
- Having been exposed to an altitude of more than 900 m in the last 8 months
- Having performed a study with hypoxia in the last 8 months
- Suffering from any of the following diseases/pathologies: diabetes, sleep apnoea, dyslexia, colour blindness, blurred vision, respiratory and/or neuromuscular diseases.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Performance and Sport Rehabilitation Laobratory. University of Castilla-La Mancha
Toledo, 45004
About this study
Official title: Effects of Different Hypoxia Exposures on Cognitive Performance in Healthy Adults
The goal of this clinical trial is to determine the effects of different hypoxia exposures (FiO2 = 11%, 13%, 15%, and 21%) on cognitive performance in healthy adults. The main questions it aims to answer are:
- What is the best hypoxia exposure to improve reaction time, anticipation, attention and memory tasks?
- Which hypoxia exposure causes the greatest detriments in cognitive function?
Read the detailed description
Participants will completed four trials in a single-blinded crossover randomised control trial. In the first session, individuals familiarised with the different cognitive tests and hypoxic exposures. In the next four experimental trials (separated by 1 week), participants arrived at the laboratory and rested in a seated for 10 min. The vital signs (i.e., SpO2, HR, blood pressure) and Lake Louise Score were recorded prior to mask placed and start with in one of the four conditions: a) PLA/NOR, b) FiO2=15%, c) FiO2=13% or FiO2=11%. In this hypoxic condition the participant will spend a total of 45 min, of which 30 min was at rest, and the other 15 min was performing the cognitive tasks (i.e., memory test, go/no-go test, eriksen flanker test, anticipation task and reaction time test).
- Conditions
- Hypoxia
- Being tested
- Hypoxia
- Keywords
- cognitive, anticipation, memory, attention, reaction time
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypoxiaOther
Also called hypoxic exposure
Hypoxic exposure: FiO2 = 11% Hypoxic exposure: FiO2 = 13% Hypoxic exposure: FiO2 = 15% Hypoxic exposure / placebo: FiO2 = 21%
| Study group | Role | What they receive |
|---|---|---|
| 11% FiO2 | Experimental | Hypoxic exposure: fraction of oxygen inspired (FiO2) = 11% (~5100 m, ~16735 ft) Receives: Other: Hypoxia |
| 13% FiO2 | Experimental | Hypoxic exposure: fraction of oxygen inspired (FiO2) = 13% (~3800 m, ~12470 ft) Receives: Other: Hypoxia |
| 15% FiO2 | Experimental | Hypoxic exposure: fraction of oxygen inspired (FiO2) = 15% (~2750 m, ~9000 ft) Receives: Other: Hypoxia |
| PLA / 21% FiO2 | Placebo comparator | Hypoxic exposure / placebo condition: fraction of oxygen inspired (FiO2) = 21% (sea level) Receives: Other: Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory
To study the modulation of memory storage processes, three 20-item word lists were created. Each word in the list will be presented for 5 s. This will be followed by a 100 s memory consolidation interval, after which there will be a 120 s period in which as many words as the participants can remember will be written down (First time). After 15 min, participants will perform a recall task (Second time) in which they will have to rewrite all the words they remember at that time.
Measured: During each hypoxic condition
Attention
The ability of maintaining the attention and inhibiting an appropriate response will be measured by "Go/No-Go Test" [fastest, slowest, and average response time (in seconds), and successful attempts (percentage; %)] and "Eriksen Flanker Test" [congruent and incongruent reaction time (in seconds)].
Measured: During each hypoxic condition
Anticipation
Visual acuity related to hand-eye coordination and anticipation will be assessed using the Bassin Anticipation Timer instrument. The best anticipation time (in seconds) of each condition (5, 10 and 15 mph) will be taken.
Measured: During each hypoxic condition
Reaction time
Reaction time (in seconds) shall be assessed with the Dynavision™ D2 Visomotor Device using the "Reaction Time Test". In this test the fastest visual, motor and physical reaction time will be measured.
Measured: During each hypoxic condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start20 Mar 2024
- Primary completion5 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxiaStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318312
- Sponsor's protocol ID
- HYP_MR_2024
- Acronym
- HYPCOG
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramirez-delaCruz M, Ortiz-Sanchez D, Bravo-Sanchez A, Portillo J, Esteban-Garcia P, Abian-Vicen J. Effects of different exposures to normobaric hypoxia on cognitive performance in healthy young adults.: Normobaric hypoxia and cognitive performance. Physiol Behav. 2025 Jan 1;288:114747. doi: 10.1016/j.physbeh.2024.114747. Epub 2024 Nov 14.
PubMed 39547435
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Hypoxia Exposures on Cognitive Performance in Healthy Adults
- ClinicalTrials.gov ID
- NCT06318312
- Acronym / sponsor ID
- HYPCOG / HYP_MR_2024
- Conditions
- Hypoxia
- Keywords
- cognitive, anticipation, memory, attention, reaction time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 19 Mar 2024 (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 goal of this clinical trial is to determine the effects of different hypoxia exposures (FiO2 = 11%, 13%, 15%, and 21%) on cognitive performance in healthy adults. The main questions it aims to answer are:
- What is the best hypoxia exposure to improve reaction time, anticipation, attention and memory tasks?
- Which hypoxia exposure causes the greatest detriments in cognitive function?
Detailed description
Participants will completed four trials in a single-blinded crossover randomised control trial. In the first session, individuals familiarised with the different cognitive tests and hypoxic exposures. In the next four experimental trials (separated by 1 week), participants arrived at the laboratory and rested in a seated for 10 min. The vital signs (i.e., SpO2, HR, blood pressure) and Lake Louise Score were recorded prior to mask placed and start with in one of the four conditions: a) PLA/NOR, b) FiO2=15%, c) FiO2=13% or FiO2=11%. In this hypoxic condition the participant will spend a total of 45 min, of which 30 min was at rest, and the other 15 min was performing the cognitive tasks (i.e., memory test, go/no-go test, eriksen flanker test, anticipation task and reaction time test).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 11% FiO2 | Experimental | Other: HypoxiaHypoxic exposure: fraction of oxygen inspired (FiO2) = 11% (~5100 m, ~16735 ft) |
| 13% FiO2 | Experimental | Other: HypoxiaHypoxic exposure: fraction of oxygen inspired (FiO2) = 13% (~3800 m, ~12470 ft) |
| 15% FiO2 | Experimental | Other: HypoxiaHypoxic exposure: fraction of oxygen inspired (FiO2) = 15% (~2750 m, ~9000 ft) |
| PLA / 21% FiO2 | Placebo comparator | Other: HypoxiaHypoxic exposure / placebo condition: fraction of oxygen inspired (FiO2) = 21% (sea level) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Physically active individuals ( >150 min/week moderate physical activity or >75 min/week vigorous physical activity)
- Non-smokers
- Individuals without serious and undiagnosed health problems
Key exclusion criteria (5 listed)
- Pregnancy and/or breastfeeding
- Residing at an altitude of more than 1300 m
- Having been exposed to an altitude of more than 900 m in the last 8 months
- Having performed a study with hypoxia in the last 8 months
- Suffering from any of the following diseases/pathologies: diabetes, sleep apnoea, dyslexia, colour blindness, blurred vision, respiratory and/or neuromuscular diseases.
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 |
|---|---|---|
| HypoxiaAlso: hypoxic exposureHypoxic exposure: FiO2 = 11% Hypoxic exposure: FiO2 = 13% Hypoxic exposure: FiO2 = 15% Hypoxic exposure / placebo: FiO2 = 21% | Other | 11% FiO2, 13% FiO2, 15% FiO2, PLA / 21% FiO2 |
Primary outcome
Memory
Time frame: During each hypoxic condition
To study the modulation of memory storage processes, three 20-item word lists were created. Each word in the list will be presented for 5 s. This will be followed by a 100 s memory consolidation interval, after which there will be a 120 s period in which as many words as the participants can remember will be written down (First time). After 15 min, participants will perform a recall task (Second time) in which they will have to rewrite all the words they remember at that time.
Attention
Time frame: During each hypoxic condition
The ability of maintaining the attention and inhibiting an appropriate response will be measured by "Go/No-Go Test" [fastest, slowest, and average response time (in seconds), and successful attempts (percentage; %)] and "Eriksen Flanker Test" [congruent and incongruent reaction time (in seconds)].
Anticipation
Time frame: During each hypoxic condition
Visual acuity related to hand-eye coordination and anticipation will be assessed using the Bassin Anticipation Timer instrument. The best anticipation time (in seconds) of each condition (5, 10 and 15 mph) will be taken.
Reaction time
Time frame: During each hypoxic condition
Reaction time (in seconds) shall be assessed with the Dynavision™ D2 Visomotor Device using the "Reaction Time Test". In this test the fastest visual, motor and physical reaction time will be measured.
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 8 May 2024.
- Derived from this study: PubMed 39547435Ramirez-delaCruz M, Ortiz-Sanchez D, Bravo-Sanchez A, Portillo J, Esteban-Garcia P, Abian-Vicen J. Effects of different exposures to normobaric hypoxia on cognitive performance in healthy young adults.: Normobaric hypoxia and cognitive performance. Physiol Behav. 2025 Jan 1;288:114747. doi: 10.1016/j.physbeh.2024.114747. Epub 2024 Nov 14.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxia in people with Hypoxia, run by University of Castilla-La Mancha at 1 site 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 3 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Memory (time frame: During each hypoxic condition). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06318312, which also lists 1 linked publication.
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 8 May 2024.