A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance
Primary Purpose
Mental Fatigue, Near Infrared Spectroscopy, NIRS
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Hypoxia
Normoxia
Sponsored by
About this trial
This is an interventional basic science trial for Mental Fatigue
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Human Physiology - MFYSRecruiting
- Human Physiology - MFYSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mental fatigue
Control MF
Arm Description
Stroop task
Emotionally neutral documentary
Outcomes
Primary Outcome Measures
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.
Mental fatigue
Results of a visual analogue scale for mental fatigue
Secondary Outcome Measures
Cognition
Results of the Joggle cognition test battery (accuracy and reaction time
Fine motor control
Results of the vienna test system (MLS) =accuraccy and reaction time
Visuomotor control
Results of a visuomotor fitlight task = accuracy and reaction time
Full Information
NCT ID
NCT05100667
First Posted
January 28, 2021
Last Updated
April 27, 2022
Sponsor
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT05100667
Brief Title
A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance
Official Title
A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Fatigue, Near Infrared Spectroscopy, NIRS, Hypoxia, Cerebral Heamodynamics, Cognition
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized blinded placebo-controlled counterbalanced crossover design
Masking
Participant
Masking Description
We will inform the participants in a way that explains the study as an investigation about the influence of different cognitive tasks on a subsequent physical task at various altitudes looking at other physiological outcome measures.
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mental fatigue
Arm Type
Experimental
Arm Description
Stroop task
Arm Title
Control MF
Arm Type
Placebo Comparator
Arm Description
Emotionally neutral documentary
Intervention Type
Other
Intervention Name(s)
Hypoxia
Other Intervention Name(s)
Mental fatigue
Intervention Description
altitude (3800m)
Intervention Type
Other
Intervention Name(s)
Normoxia
Other Intervention Name(s)
Mental fatigue
Intervention Description
sea level
Primary Outcome Measure Information:
Title
Cerebral oxygenation
Description
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.
Time Frame
2 hours
Title
Mental fatigue
Description
Results of a visual analogue scale for mental fatigue
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Cognition
Description
Results of the Joggle cognition test battery (accuracy and reaction time
Time Frame
20 minutes
Title
Fine motor control
Description
Results of the vienna test system (MLS) =accuraccy and reaction time
Time Frame
5 minutes
Title
Visuomotor control
Description
Results of a visuomotor fitlight task = accuracy and reaction time
Time Frame
7 minutes
Other Pre-specified Outcome Measures:
Title
Hemoglobin concentration
Description
Hemoglobin will be assessed through the analysys of 1 drop of arterial blood
Time Frame
10 minutes
Title
Blood glucose concentration
Description
Hemoglobin will be assessed through the analysys of 1 drop of arterial blood
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Facility Information:
Facility Name
Human Physiology - MFYS
City
Brussel
State/Province
Brussels
ZIP/Postal Code
1050
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonas De Wachter, MSc
Phone
026292707
Email
jonas.de.wachter@vub.be
First Name & Middle Initial & Last Name & Degree
Bart Roelands, PhD
Phone
026292707
Email
bart.roelands@vub.be
First Name & Middle Initial & Last Name & Degree
Jonas De Wachter, MSc
First Name & Middle Initial & Last Name & Degree
Matthias Proost, MSc
First Name & Middle Initial & Last Name & Degree
Bart Roelands, PhD
First Name & Middle Initial & Last Name & Degree
Jeroen Van Cutsem, PhD
Facility Name
Human Physiology - MFYS
City
Brussels
ZIP/Postal Code
1050
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonas De Wachter, MsC
Phone
026292707
Email
jonas.de.wachter@vub.be
First Name & Middle Initial & Last Name & Degree
Jonas De Wachter, MSc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance
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