Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT03303118
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2017-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Hypobaria vs Hypoxia on Cerebral Functions.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-Blind study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2017-10-02', 'studyFirstSubmitQcDate': '2017-10-02', 'lastUpdatePostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cerebral vaso-reactivity', 'timeFrame': '8 Minutes per test', 'description': 'Cerebral vasoreactivity after 1 minute hyperventilation and 3 minutes breathing of 5% CO2 mixture.'}], 'primaryOutcomes': [{'measure': 'Concentration performance', 'timeFrame': '4 minutes per test', 'description': 'Performance of concentration at different altitude levels.'}], 'secondaryOutcomes': [{'measure': 'EEG micro-states', 'timeFrame': '5 minutes per record', 'description': '5 minutes recording in each conditions, eyes closed, at rest.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypoxia', 'Brain', 'Cerebral vaso-reactivity', 'EEG', 'Concentration performance', 'Cerebral oxygenation', 'Cerebral blood-flow', 'Heart rate variability'], 'conditions': ['Cerebral Hypoxia']}, 'referencesModule': {'references': [{'pmid': '32097541', 'type': 'DERIVED', 'citation': 'Aebi MR, Bourdillon N, Kunz A, Bron D, Millet GP. Specific effect of hypobaria on cerebrovascular hypercapnic responses in hypoxia. Physiol Rep. 2020 Feb;8(4):e14372. doi: 10.14814/phy2.14372.'}]}, 'descriptionModule': {'briefSummary': "The investigators will investigate the effect of hypobaria and hypoxia on physiological responses such as: oxygen saturation, heart rate, cerebral blood flow, cerebral oxygenation, brain's activity and concentration performance.", 'detailedDescription': "The main goal of this project is to investigate how hypoxia affects cognitive functions. The KLT-R test asses the concentration level of a person. Subjects will do this test at different simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Investigators' first hypothesis is that concentration level will be altered by hypoxia. The higher altitude the subjects are, the more the concentration would be altered. KLT-R performance would be impaired by hypoxia compare to sea level performance.\n\nThe primary endpoint of this project is to investigate how KLT-R performance is affected by the different hypoxic conditions. KLT-R test will be passed nine times in total during the test visit. There will be a pre-test; a test at each of the conditions (3000m HH, 5500m HH, 5500m NH and 5500m HN); between each condition at sea level (to have a new baseline before each condition) and a post-test at the end of the protocol. To avoid influence of fatigue, all conditions will be randomized.\n\nThe second endpoint of this study is how the brain electrical activity is modulated by hypoxia. Micro-states also will be measure during hypobaric hypoxia conditions (3000m HH and 5500m HH)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No history of flight sickness\n* No relevant medical diseases\n* Age 18 - 40 years\n* Written consent acceptance\n\nExclusion Criteria:\n\n* Known pathologies\n* Relevant medical disorders\n* Drug addiction\n* Anemia or poor health\n* People who have already had problems with elevation'}, 'identificationModule': {'nctId': 'NCT03303118', 'acronym': 'Hypoxia', 'briefTitle': 'The Effects of Hypobaria vs Hypoxia on Cerebral Functions.', 'organization': {'class': 'OTHER', 'fullName': 'Fliegerärztliches Institut'}, 'officialTitle': "The Effects of Hypobaria vs Hypoxia on Cerebral Vasoreactivity, Brain's Electrical Activity and Concentration Performance on Pilots.", 'orgStudyIdInfo': {'id': '2017-00752'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Left', 'description': 'No product administration will be done in this study.', 'interventionNames': ['Other: Hypoxia']}], 'interventions': [{'name': 'Hypoxia', 'type': 'OTHER', 'description': 'No drug or product will be used in this study. No medication will be give to the participants. No arm will be used for product administration.', 'armGroupLabels': ['Left']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8600', 'city': 'Dübendorf', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Mathias Aebi', 'geoPoint': {'lat': 47.39724, 'lon': 8.61872}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results will be shared in scientific publications by the end of this year and in 2018.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fliegerärztliches Institut', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med Denis Bron', 'investigatorFullName': 'Mathias Aebi, PhD', 'investigatorAffiliation': 'Fliegerärztliches Institut'}}}}