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A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance

Sponsor
Vrije Universiteit Brussel (Other)
Overall Status
Recruiting
CT.gov ID
NCT05100667
Collaborator
(none)
15
Enrollment
2
Locations
2
Arms
20
Anticipated Duration (Months)
7.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hypoxia
  • Other: Normoxia
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
randomized blinded placebo-controlled counterbalanced crossover designrandomized blinded placebo-controlled counterbalanced crossover design
Masking:
Single (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.
Primary Purpose:
Basic Science
Official Title:
A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mental fatigue

Stroop task

Other: Hypoxia
altitude (3800m)
Other Names:
  • Mental fatigue

    • Other: Normoxia
    sea level
    Other Names:
  • Mental fatigue

    		•
    Placebo Comparator: Control MF

    Emotionally neutral documentary

    Other: Hypoxia
    altitude (3800m)
    Other Names:
  • Mental fatigue

    • Other: Normoxia
    sea level
    Other Names:
  • Mental fatigue

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cerebral oxygenation [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.

    2. Mental fatigue [60 minutes]

      Results of a visual analogue scale for mental fatigue

    Secondary Outcome Measures

    1. Cognition [20 minutes]

      Results of the Joggle cognition test battery (accuracy and reaction time

    2. Fine motor control [5 minutes]

      Results of the vienna test system (MLS) =accuraccy and reaction time

    3. Visuomotor control [7 minutes]

      Results of a visuomotor fitlight task = accuracy and reaction time

    Other Outcome Measures

    1. Hemoglobin concentration [10 minutes]

      Hemoglobin will be assessed through the analysys of 1 drop of arterial blood

    2. Blood glucose concentration [10 minutes]

      Hemoglobin will be assessed through the analysys of 1 drop of arterial blood

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Human Physiology - MFYS Brussel Brussels Belgium 1050
    2 Human Physiology - MFYS Brussels Belgium 1050

    Sponsors and Collaborators

    • Vrije Universiteit Brussel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Romain Meeusen, Principal investigator, Vrije Universiteit Brussel
    ClinicalTrials.gov Identifier:
    NCT05100667
    Other Study ID Numbers:
    • 796
    First Posted:
    Oct 29, 2021
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:
    Fatigue
    Hypoxia
    Mental Fatigue

    Study Results

    No Results Posted as of Apr 28, 2022