Mental FatigueNCT05100667
A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance
A study testing Hypoxia and Normoxia in people with Mental Fatigue and Near Infrared Spectroscopy, run by Vrije Universiteit Brussel at 2 sites in Belgium.
Trial summary
Introduction Both Mental Fatigue (MF) and hypoxia impair multiple aspects of cognitive functioning. The decline in cognitive functioning in hypoxic conditions is associated with alterations in brain oxygenation and hemodynamic responses. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Fatigue, Near Infrared Spectroscopy, NIRS
- What is being tested?
- Hypoxia and Normoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 May 2022to 1 Jan 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (No neurological or cardiovascular disorders)
- Male or female
- No medication
- Non-smoker
- Between 18 and 35 years old
- Recreational athlete population; performance level 2 or 3 for men according to De Pauw et al. (2013)[29] and performance level 2 or 3 for woman according to Decroix et al. (2015)
- Non-acclimatized to altitude (at least 2 months)
Who cannot join
- Injuries
- Acclimated to altitude
- Use of medication
- Use of caffeine and heavy efforts 24 hours prior each trial
- Not eating a standardized meal, the morning of each trial
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Human Physiology - MFYS
Brussels, Brussels Capital, 1050
Jonas De Wachter, MSc, 026292707, jonas.de.wachter@vub.be
Bart Roelands, PhD, 026292707, bart.roelands@vub.be
- Recruiting
Human Physiology - MFYS
Brussels, 1050
Jonas De Wachter, MsC, 026292707, jonas.de.wachter@vub.be
Jonas De Wachter, MSc
About this study
Introduction Both Mental Fatigue (MF) and hypoxia impair multiple aspects of cognitive functioning. The decline in cognitive functioning in hypoxic conditions is associated with alterations in brain oxygenation and hemodynamic responses. These hemodynamic responses are preferably measured at the prefrontal cortex, an area of the brain that is known for its executive function and role in decision making, planning, attention and (short-term) memory. This study will investigate the role of prefrontal cortex oxygenation during the development of mental fatigue and during cognitive performances by altering the ambient oxygen availability through normobaric hypoxia (3800m; 12,9% O2) and normoxia.
Methods Subjects will perform four trials in a sound-insulated climate chamber (20°C and 40% RH). Upon entry in the climatic chamber participants will adapt to the environment for 30 minutes. Next, they will perform a modified cognitive test battery "cognition", a fine motor task "Motor Performance Series" and a visuomotor-fitlight task before and after a 60-minute individualized Stroop task or control task (randomized. blinded, placebo controlled, counter-balanced, cross-over design). Nearinfrared spectroscopy (NIRS) will be used to assess hemodynamic changes (oxygenated hemoglobin (O2Hb), deoxygenated-hemoglobin (HHb) and total hemoglobin (tHb)) at the PFC.
Hypotheses 1) MF will lead to earlier changes in the prefrontal NIRS-parameters (O2Hb, HHb, tHb) with lower oxygen availability. 2) The effects of MF on cognitive performance manifest itself to a greater extent with lower oxygen availability.3) Visuomotor performance declines to a greater extent due to MF with lower oxygen availability.
- Conditions
- Mental Fatigue, Near Infrared Spectroscopy, NIRS, Hypoxia, Cerebral Heamodynamics, Cognition
- Being tested
- Hypoxia, Normoxia
- Medical subject headings
- Mental Fatigue, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypoxiaOther
Also called Mental fatigue
altitude (3800m)
NormoxiaOther
Also called Mental fatigue
sea level
| Study group | Role | What they receive |
|---|---|---|
| Mental fatigue | Experimental | Stroop task Receives: Other: Hypoxia; Other: Normoxia |
| Control MF | Placebo comparator | Emotionally neutral documentary Receives: Other: Hypoxia; Other: Normoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral oxygenation
Prefrontal cortex oxygenation = relative changes in oxy- and deoxy hemoglobin at the prefrontal cortex. During the whole frame, participants are equipped with a Near Infrared Spectroscopy device that measures cerebral oxygenation continuously at 10hz.
Measured: 2 hours
Mental fatigue
Results of a visual analogue scale for mental fatigue
Measured: 60 minutes
Secondary outcomes (3)
Cognition
Results of the Joggle cognition test battery (accuracy and reaction time
Measured: 20 minutes
Fine motor control
Results of the vienna test system (MLS) =accuraccy and reaction time
Measured: 5 minutes
Visuomotor control
Results of a visuomotor fitlight task = accuracy and reaction time
Measured: 7 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 May 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental FatigueStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- Model description
- randomized blinded placebo-controlled counterbalanced crossover design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Meeusen, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100667
- Sponsor's protocol ID
- 796
- Status last verified
- Apr 2022
- First submitted
- 28 Jan 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance
- ClinicalTrials.gov ID
- NCT05100667
- Acronym / sponsor ID
- 796
- Conditions
- Mental Fatigue, Near Infrared Spectroscopy, NIRS, Hypoxia, Cerebral Heamodynamics, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 29 Oct 2021 (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.
Introduction Both Mental Fatigue (MF) and hypoxia impair multiple aspects of cognitive functioning. The decline in cognitive functioning in hypoxic conditions is associated with alterations in brain oxygenation and hemodynamic responses. These hemodynamic responses are preferably measured at the prefrontal cortex, an area of the brain that is known for its executive function and role in decision making, planning, attention and (short-term) memory. This study will investigate the role of prefrontal cortex oxygenation during the development of mental fatigue and during cognitive performances by altering the ambient oxygen availability through normobaric hypoxia (3800m; 12,9% O2) and normoxia.
Methods Subjects will perform four trials in a sound-insulated climate chamber (20°C and 40% RH). Upon entry in the climatic chamber participants will adapt to the environment for 30 minutes. Next, they will perform a modified cognitive test battery "cognition", a fine motor task "Motor Performance Series" and a visuomotor-fitlight task before and after a 60-minute individualized Stroop task or control task (randomized. blinded, placebo controlled, counter-balanced, cross-over design). Nearinfrared spectroscopy (NIRS) will be used to assess hemodynamic changes (oxygenated hemoglobin (O2Hb), deoxygenated-hemoglobin (HHb) and total hemoglobin (tHb)) at the PFC.
Hypotheses 1) MF will lead to earlier changes in the prefrontal NIRS-parameters (O2Hb, HHb, tHb) with lower oxygen availability. 2) The effects of MF on cognitive performance manifest itself to a greater extent with lower oxygen availability.3) Visuomotor performance declines to a greater extent due to MF with lower oxygen availability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized blinded placebo-controlled counterbalanced crossover design
| Arm | Type | Receives |
|---|---|---|
| Mental fatigue | Experimental | Other: Hypoxia, Other: NormoxiaStroop task |
| Control MF | Placebo comparator | Other: Hypoxia, Other: NormoxiaEmotionally neutral documentary |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy (No neurological or cardiovascular disorders)
- Male or female
- No medication
- Non-smoker
- Between 18 and 35 years old
Key exclusion criteria (5 listed)
- Injuries
- Acclimated to altitude
- Use of medication
- Use of caffeine and heavy efforts 24 hours prior each trial
- Not eating a standardized meal, the morning of each trial
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: Mental fatiguealtitude (3800m) | Other | Control MF, Mental fatigue |
| NormoxiaAlso: Mental fatiguesea level | Other | Control MF, Mental fatigue |
Primary outcome
Cerebral oxygenation
Time frame: 2 hours
Prefrontal cortex oxygenation = relative changes in oxy- and deoxy hemoglobin at the prefrontal cortex. During the whole frame, participants are equipped with a Near Infrared Spectroscopy device that measures cerebral oxygenation continuously at 10hz.
Mental fatigue
Time frame: 60 minutes
Results of a visual analogue scale for mental fatigue
3 secondary outcomes
Cognition
Time frame: 20 minutes
Fine motor control
Time frame: 5 minutes
Visuomotor control
Time frame: 7 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxia and Normoxia in people with Mental Fatigue and Near Infrared Spectroscopy, run by Vrije Universiteit Brussel at 2 sites in Belgium.
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 7 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: status not confirmed, as of the sponsor's last update on 28 Apr 2022. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral oxygenation (time frame: 2 hours). The study lists 2 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 28 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.