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

April 27, 2022 updated by: Romain Meeusen, Vrije Universiteit Brussel

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1050
        • Recruiting
        • Human Physiology - MFYS
        • Contact:
        • Principal Investigator:
          • Jonas De Wachter, MSc
    • Brussels
      • Brussel, Brussels, Belgium, 1050
        • Recruiting
        • Human Physiology - MFYS
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jonas De Wachter, MSc
        • Principal Investigator:
          • Matthias Proost, MSc
        • Principal Investigator:
          • Bart Roelands, PhD
        • Principal Investigator:
          • Jeroen Van Cutsem, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 hours
Mental fatigue
Time Frame: 60 minutes
Results of a visual analogue scale for mental fatigue
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition
Time Frame: 20 minutes
Results of the Joggle cognition test battery (accuracy and reaction time
20 minutes
Fine motor control
Time Frame: 5 minutes
Results of the vienna test system (MLS) =accuraccy and reaction time
5 minutes
Visuomotor control
Time Frame: 7 minutes
Results of a visuomotor fitlight task = accuracy and reaction time
7 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin concentration
Time Frame: 10 minutes
Hemoglobin will be assessed through the analysys of 1 drop of arterial blood
10 minutes
Blood glucose concentration
Time Frame: 10 minutes
Hemoglobin will be assessed through the analysys of 1 drop of arterial blood
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vrije Universiteit Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2022

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

January 1, 2024

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (ACTUAL)

October 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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