Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT05100667
Status:
UNKNOWN
Last Update Posted:
2022-04-28
First Post:
2021-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005222', 'term': 'Mental Fatigue'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '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.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomized blinded placebo-controlled counterbalanced crossover design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-27', 'studyFirstSubmitDate': '2021-01-28', 'studyFirstSubmitQcDate': '2021-10-19', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemoglobin concentration', 'timeFrame': '10 minutes', 'description': 'Hemoglobin will be assessed through the analysys of 1 drop of arterial blood'}, {'measure': 'Blood glucose concentration', 'timeFrame': '10 minutes', 'description': 'Hemoglobin will be assessed through the analysys of 1 drop of arterial blood'}], 'primaryOutcomes': [{'measure': 'Cerebral oxygenation', 'timeFrame': '2 hours', 'description': '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.'}, {'measure': 'Mental fatigue', 'timeFrame': '60 minutes', 'description': 'Results of a visual analogue scale for mental fatigue'}], 'secondaryOutcomes': [{'measure': 'Cognition', 'timeFrame': '20 minutes', 'description': 'Results of the Joggle cognition test battery (accuracy and reaction time'}, {'measure': 'Fine motor control', 'timeFrame': '5 minutes', 'description': 'Results of the vienna test system (MLS) =accuraccy and reaction time'}, {'measure': 'Visuomotor control', 'timeFrame': '7 minutes', 'description': 'Results of a visuomotor fitlight task = accuracy and reaction time'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Fatigue', 'Near Infrared Spectroscopy', 'NIRS', 'Hypoxia', 'Cerebral Heamodynamics', 'Cognition']}, 'descriptionModule': {'briefSummary': '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.\n\nMethods 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.\n\nHypotheses 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy (No neurological or cardiovascular disorders)\n* Male or female\n* No medication\n* Non-smoker\n* Between 18 and 35 years old\n* 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)\n* Non-acclimatized to altitude (at least 2 months)\n\nExclusion Criteria:\n\n* Injuries\n* Acclimated to altitude\n* Use of medication\n* Use of caffeine and heavy efforts 24 hours prior each trial\n* Not eating a standardized meal, the morning of each trial'}, 'identificationModule': {'nctId': 'NCT05100667', 'briefTitle': 'A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance', 'organization': {'class': 'OTHER', 'fullName': 'Vrije Universiteit Brussel'}, 'officialTitle': 'A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance', 'orgStudyIdInfo': {'id': '796'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mental fatigue', 'description': 'Stroop task', 'interventionNames': ['Other: Hypoxia', 'Other: Normoxia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control MF', 'description': 'Emotionally neutral documentary', 'interventionNames': ['Other: Hypoxia', 'Other: Normoxia']}], 'interventions': [{'name': 'Hypoxia', 'type': 'OTHER', 'otherNames': ['Mental fatigue'], 'description': 'altitude (3800m)', 'armGroupLabels': ['Control MF', 'Mental fatigue']}, {'name': 'Normoxia', 'type': 'OTHER', 'otherNames': ['Mental fatigue'], 'description': 'sea level', 'armGroupLabels': ['Control MF', 'Mental fatigue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1050', 'city': 'Brussels', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Jonas De Wachter, MSc', 'role': 'CONTACT', 'email': 'jonas.de.wachter@vub.be', 'phone': '026292707'}, {'name': 'Bart Roelands, PhD', 'role': 'CONTACT', 'email': 'bart.roelands@vub.be', 'phone': '026292707'}, {'name': 'Jonas De Wachter, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matthias Proost, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bart Roelands, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jeroen Van Cutsem, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Human Physiology - MFYS', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1050', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Jonas De Wachter, MsC', 'role': 'CONTACT', 'email': 'jonas.de.wachter@vub.be', 'phone': '026292707'}, {'name': 'Jonas De Wachter, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Human Physiology - MFYS', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Romain Meeusen', 'investigatorAffiliation': 'Vrije Universiteit Brussel'}}}}