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

NCT05100667 | Unknown DMC

• 1 other identifier: 796
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Mental Fatigue; Near Infrared Spectroscopy; NIRS; Hypoxia; Cerebral Heamodynamics; Cognition

Outcome Measures

Primary Outcomes (2)

• 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.

  2 hours

• Mental fatigue

  Results of a visual analogue scale for mental fatigue

  60 minutes

Secondary Outcomes (3)

• Cognition

  20 minutes

• Fine motor control

  5 minutes

• Visuomotor control

  7 minutes

Other Outcomes (2)

• Hemoglobin concentration

  10 minutes

• Blood glucose concentration

  10 minutes

Study Arms (2)

Mental fatigue

EXPERIMENTAL

Stroop task

Other: Hypoxia; Other: Normoxia

Control MF

PLACEBO COMPARATOR

Emotionally neutral documentary

Other: Hypoxia; Other: Normoxia

Interventions

Hypoxia OTHER

altitude (3800m)

Also known as: Mental fatigue

Control MF; Mental fatigue

Normoxia OTHER

sea level

Also known as: Mental fatigue

Control MF; Mental fatigue

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (2)

Human Physiology - MFYS

Brussels, Brussels Capital, 1050, Belgium

RECRUITING

Human Physiology - MFYS

Brussels, 1050, Belgium

RECRUITING

MeSH Terms

Conditions

Mental Fatigue; Hypoxia

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Signs and Symptoms, Respiratory

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: randomized blinded placebo-controlled counterbalanced crossover design

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: October 29, 2021
• Study Start: May 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: January 1, 2024
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

BE (2)