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NCT05100667
A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance
NA trial testing Hypoxia in Mental Fatigue in 15 participants. Status unknown.
1 March 2023
Quick facts
| Lead sponsor | Vrije Universiteit Brussel |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 15 |
| Start date | 1 May 2022 |
| Primary completion | 1 March 2023 |
| Estimated completion | 1 January 2024 |
| Sites | 2 locations across Belgium |
Drugs / interventions tested
- Hypoxia — full drug profile →
- Normoxia
Conditions studied
- Mental Fatigue — all drugs for Mental Fatigue →
- Near Infrared Spectroscopy — all drugs for Near Infrared Spectroscopy →
- NIRS — all drugs for NIRS →
- Hypoxia — all drugs for Hypoxia →
Sponsor
Vrije Universiteit Brussel — full company profile →
Who can join
Adults 18 to 45, any sex, with Mental Fatigue or Near Infrared Spectroscopy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Currently open trials in the same condition.
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Other Vrije Universiteit Brussel trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05100667 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vrije Universiteit Brussel
- Last refreshed: 28 April 2022
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