Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-30 @ 6:11 AM
Study NCT ID:
NCT03126669
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2017-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxygen as a Limiting Factor for Performing Multitasking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2017-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2017-04-20', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive/Attention Symbol-Digit Modality Test (SDMT)', 'timeFrame': '45 minutes', 'description': 'Three different forms of the SDMT were used in each evaluation session. The first was a try-out for the test, ensuring understanding of the task. The second tests the ability to per-form an individual task. The third form was used together with the motor test for examin-ing dual task performance. Standard administration procedures were followed as indicat-ed in the test manual. The score of the test is the number of correct substitutions during 90-second interval.'}, {'measure': 'Motor task: transferring of beans', 'timeFrame': '45 minutes', 'description': 'Motor performance was evaluated by the Motor Assessment Scale test (MAS) - transfer-ring units of beans one by one between two tea cups an arm length away.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperbaric oxygen', 'multitasking performance', 'cognitive funcitons'], 'conditions': ['Cognitive Change']}, 'descriptionModule': {'briefSummary': 'The aim of the present study was to evaluate whether hyperbaric oxygen (HBO) environment, with increased oxygen supply to the brain, will enable better performance of complex and/or multiple activities.', 'detailedDescription': 'The Brain uses 20% of the total oxygen supply consumed by the entire body. Even though, less than 10% of the brain is active at every given time, the brain utilizes almost all the oxygen delivered. In order to perform different tasks or more than one task (multi-tasking), the oxygen supply is shifted from one brain region to another, via modulation of blood perfusion.\n\nThe aim of the present study was to evaluate whether hyperbaric oxygen (HBO) environment, with increased oxygen supply to the brain, will enable better performance of complex and/or multiple activities.\n\nMethods: a prospective, double blind randomized control, cross over trial including healthy volunteers. Participants were asked to perform a cognitive task, a motor task and a simultaneous cognitive-motor task (multi-tasking). Participants were randomized to perform the tasks at 2 environments: (a) normobaric air (1ATA 21% oxygen) (b) HBO (2ATA 100% oxygen). Two weeks later participants were crossed to the alternative environment. Blinding of the normobaric environment was achieved in the same chamber with masks on while hyperbaric sensation was simulated by increasing pressure in the first minute and gradually decreasing to normobaric environment prior to tasks performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers,\n* minimum of 12 years of formal education\n\nExclusion Criteria:\n\n* any inner ear pathologies,\n* any lung disease,\n* any mental or physical limitation of participat in going into oxygen chamber environment'}, 'identificationModule': {'nctId': 'NCT03126669', 'briefTitle': 'Oxygen as a Limiting Factor for Performing Multitasking', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Oxygen as a Limiting Factor for Performing Multitasking: Functional Evaluation Under Normobaric and Hyperbaric Oxygenation of Healthy Participants', 'orgStudyIdInfo': {'id': '213/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treratment', 'description': '100% oxygen at 2 ATA at the hyperbaric chamber', 'interventionNames': ['Device: Hyperbaric oxygen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'normal air, in the hyperbaric chamber', 'interventionNames': ['Device: Hyperbaric chamber, normal air']}], 'interventions': [{'name': 'Hyperbaric oxygen', 'type': 'DEVICE', 'description': 'Breathing 100% oxygen at 2ATA in the hyperbaric chamber', 'armGroupLabels': ['Treratment']}, {'name': 'Hyperbaric chamber, normal air', 'type': 'DEVICE', 'description': 'Hyperbaric chamber with normal air', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Ẕerifin', 'country': 'Israel', 'facility': 'Assaf-Harofeh Medical Center', 'geoPoint': {'lat': 31.95731, 'lon': 34.84852}}], 'overallOfficials': [{'name': 'Shai a Efrati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asaf-Harofhe MC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}