Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-02 @ 2:28 AM
Study NCT ID:
NCT04053556
Status:
COMPLETED
Last Update Posted:
2019-08-12
First Post:
2016-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Performance After a Night Shift in Internal Medicine Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}, {'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-09', 'studyFirstSubmitDate': '2016-10-26', 'studyFirstSubmitQcDate': '2019-08-09', 'lastUpdatePostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurological evaluation using Paced Auditory Serial Addition Test (PASAT)', 'timeFrame': 'Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.', 'description': 'Post on-call cognition assessment'}, {'measure': 'Burn Out', 'timeFrame': 'through study completion, an average of one year', 'description': 'Maslach questionaire filled by participant'}, {'measure': 'Conners Continuous Performance Test 2 (CPT)', 'timeFrame': 'Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.', 'description': 'Post on-call attention test'}, {'measure': 'Rey auditory verbal learning test (RAVLT)', 'timeFrame': 'Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.', 'description': 'Post on-call cognition assessment'}, {'measure': 'F-A-S test', 'timeFrame': 'Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.', 'description': 'Post on-call verbal fluency'}, {'measure': 'Direct and indirect digit span', 'timeFrame': 'Immediately after a 24 hours on call period, wth a maximum delay of 6 hours after night shift end.', 'description': 'Post on-call short-term verbal memory'}], 'secondaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'through study completion, an average of one year', 'description': 'Questionaire filled by participant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleep deprivation', 'internal medicine residency', 'on call', 'cognitive impairment', 'burn out', 'safety', 'depression'], 'conditions': ['Sleep Deprivation', 'Burnout, Professional', 'Cognition Disorders']}, 'descriptionModule': {'briefSummary': 'A quasi-experimental design where internal medicine residents in a high complexity hospital were assessed after a 24-hour shift for cognitive impairment by a trained neurologist.', 'detailedDescription': 'The investigators conducted a cross sectional study during the 2014-2016 period in a high complexity school hospital in Buenos Aires. Second and third year Internal Medicine residents who consented to participate were included.\n\nA neurologist conducted a cognitive evaluation to the residents who had done 24 hours shifts (with sleep deprivation) within 6 hours of its end.\n\nAuditory memory deficit was evaluated (PASAT - Paced Auditory Serial Addition Test), verbal fluency (FAS), direct and indirect Digit-Span, Rey auditory verbal learning test (RAVLT) and Continuous Performance Test 2 (CPT2).\n\nResults were presented as means of standardized scores (z score) with their interquartile range (IQR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Internal Medicine residents in formation who were on the second or third year of the Internal Medicine residency of the Italian Hospital of Buenos Aires who work 24 hours shifts and whose work day continues to a maximum of 36 total hours and who consented to the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Internal Medicine residents on the second or third year of formation.\n\nExclusion Criteria:\n\n* Denial to participate in the study or to the informed consent.'}, 'identificationModule': {'nctId': 'NCT04053556', 'briefTitle': 'Cognitive Performance After a Night Shift in Internal Medicine Residents', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'Evaluation on the Effect on Cognition and Emotional Exhaustion With a Change of Long Night Shift System Versus Reduced Night Shift in Residents of Internal Medicine', 'orgStudyIdInfo': {'id': '2489'}}, 'contactsLocationsModule': {'locations': [{'zip': 'C1199ABB', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires, Peron 4190', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Diego H Giunta, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Italiano de Buenos Aires'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Italiano de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}