Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT06318312
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2024-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Hypoxia on Cognitive Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Memory', 'timeFrame': 'During each hypoxic condition', 'description': 'To study the modulation of memory storage processes, three 20-item word lists were created. Each word in the list will be presented for 5 s. This will be followed by a 100 s memory consolidation interval, after which there will be a 120 s period in which as many words as the participants can remember will be written down (First time). After 15 min, participants will perform a recall task (Second time) in which they will have to rewrite all the words they remember at that time.'}, {'measure': 'Attention', 'timeFrame': 'During each hypoxic condition', 'description': 'The ability of maintaining the attention and inhibiting an appropriate response will be measured by "Go/No-Go Test" \\[fastest, slowest, and average response time (in seconds), and successful attempts (percentage; %)\\] and "Eriksen Flanker Test" \\[congruent and incongruent reaction time (in seconds)\\].'}, {'measure': 'Anticipation', 'timeFrame': 'During each hypoxic condition', 'description': 'Visual acuity related to hand-eye coordination and anticipation will be assessed using the Bassin Anticipation Timer instrument. The best anticipation time (in seconds) of each condition (5, 10 and 15 mph) will be taken.'}, {'measure': 'Reaction time', 'timeFrame': 'During each hypoxic condition', 'description': 'Reaction time (in seconds) shall be assessed with the Dynavision™ D2 Visomotor Device using the "Reaction Time Test". In this test the fastest visual, motor and physical reaction time will be measured.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive', 'anticipation', 'memory', 'attention', 'reaction time'], 'conditions': ['Hypoxia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine the effects of different hypoxia exposures (FiO2 = 11%, 13%, 15%, and 21%) on cognitive performance in healthy adults. The main questions it aims to answer are:\n\n* What is the best hypoxia exposure to improve reaction time, anticipation, attention and memory tasks?\n* Which hypoxia exposure causes the greatest detriments in cognitive function?', 'detailedDescription': 'Participants will completed four trials in a single-blinded crossover randomised control trial. In the first session, individuals familiarised with the different cognitive tests and hypoxic exposures. In the next four experimental trials (separated by 1 week), participants arrived at the laboratory and rested in a seated for 10 min. The vital signs (i.e., SpO2, HR, blood pressure) and Lake Louise Score were recorded prior to mask placed and start with in one of the four conditions: a) PLA/NOR, b) FiO2=15%, c) FiO2=13% or FiO2=11%. In this hypoxic condition the participant will spend a total of 45 min, of which 30 min was at rest, and the other 15 min was performing the cognitive tasks (i.e., memory test, go/no-go test, eriksen flanker test, anticipation task and reaction time test).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physically active individuals ( \\>150 min/week moderate physical activity or \\>75 min/week vigorous physical activity)\n* Non-smokers\n* Individuals without serious and undiagnosed health problems\n\nExclusion Criteria:\n\n* Pregnancy and/or breastfeeding\n* Residing at an altitude of more than 1300 m\n* Having been exposed to an altitude of more than 900 m in the last 8 months\n* Having performed a study with hypoxia in the last 8 months\n* Suffering from any of the following diseases/pathologies: diabetes, sleep apnoea, dyslexia, colour blindness, blurred vision, respiratory and/or neuromuscular diseases.'}, 'identificationModule': {'nctId': 'NCT06318312', 'acronym': 'HYPCOG', 'briefTitle': 'Effects of Hypoxia on Cognitive Performance', 'organization': {'class': 'OTHER', 'fullName': 'University of Castilla-La Mancha'}, 'officialTitle': 'Effects of Different Hypoxia Exposures on Cognitive Performance in Healthy Adults', 'orgStudyIdInfo': {'id': 'HYP_MR_2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '11% FiO2', 'description': 'Hypoxic exposure: fraction of oxygen inspired (FiO2) = 11% (\\~5100 m, \\~16735 ft)', 'interventionNames': ['Other: Hypoxia']}, {'type': 'EXPERIMENTAL', 'label': '13% FiO2', 'description': 'Hypoxic exposure: fraction of oxygen inspired (FiO2) = 13% (\\~3800 m, \\~12470 ft)', 'interventionNames': ['Other: Hypoxia']}, {'type': 'EXPERIMENTAL', 'label': '15% FiO2', 'description': 'Hypoxic exposure: fraction of oxygen inspired (FiO2) = 15% (\\~2750 m, \\~9000 ft)', 'interventionNames': ['Other: Hypoxia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLA / 21% FiO2', 'description': 'Hypoxic exposure / placebo condition: fraction of oxygen inspired (FiO2) = 21% (sea level)', 'interventionNames': ['Other: Hypoxia']}], 'interventions': [{'name': 'Hypoxia', 'type': 'OTHER', 'otherNames': ['hypoxic exposure'], 'description': 'Hypoxic exposure: FiO2 = 11% Hypoxic exposure: FiO2 = 13% Hypoxic exposure: FiO2 = 15% Hypoxic exposure / placebo: FiO2 = 21%', 'armGroupLabels': ['11% FiO2', '13% FiO2', '15% FiO2', 'PLA / 21% FiO2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45004', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Performance and Sport Rehabilitation Laobratory. University of Castilla-La Mancha', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}