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

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100667
• Other study ID #: 796
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: April 2022
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 1, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition
• Fatigue
• Hypoxia
• Mental Fatigue
• Near Infrared Spectroscopy
• NIRS

Intervention

Other:
• Hypoxia
altitude (3800m)
• Normoxia
sea level

Locations

Country	Name	City	State
Belgium	Human Physiology - MFYS	Brussel	Brussels
Belgium	Human Physiology - MFYS	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemoglobin concentration	Hemoglobin will be assessed through the analysys of 1 drop of arterial blood	10 minutes
Other	Blood glucose concentration	Hemoglobin will be assessed through the analysys of 1 drop of arterial blood	10 minutes
Primary	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
Primary	Mental fatigue	Results of a visual analogue scale for mental fatigue	60 minutes
Secondary	Cognition	Results of the Joggle cognition test battery (accuracy and reaction time	20 minutes
Secondary	Fine motor control	Results of the vienna test system (MLS) =accuraccy and reaction time	5 minutes
Secondary	Visuomotor control	Results of a visuomotor fitlight task = accuracy and reaction time	7 minutes