Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT03498560
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2018-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oluwaseun.akeju@mgh.harvard.edu', 'phone': '617-724-7200', 'title': 'Dr. Oluwaseun Johnson-Akeju', 'organization': 'Massachusetts General Hospital DACCPM'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The quality of many of the PSG recordings was poor and not interpretable. After patients enrolled, many withdrew at the time the PSG was to be placed. So, sleep was recorded for fewer patients. Blood was not analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected form the time the patient was enrolled to the completion of the follow-up assessment at 30 days.', 'description': 'This study is an observational study, not an interventional study. Thus, all adverse events patients encounter during this time period would not be related to the research study.\n\nAdverse events and other events were determined by regular chart review.', 'eventGroups': [{'id': 'EG000', 'title': 'MGH Surgery Patients', 'description': 'PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.\n\nPSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Association Between Sleep and POD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MGH Surgery Patients', 'description': 'PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.\n\nPSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.'}], 'classes': [{'title': 'Non Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '278.5', 'groupId': 'OG000', 'lowerLimit': '239.5', 'upperLimit': '315.5'}]}]}, {'title': 'Delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '313.5', 'groupId': 'OG000', 'lowerLimit': '271.3', 'upperLimit': '352.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Night before surgery, approximately 13 hours', 'description': 'Duration of sleep in delirious vs non-delirious patients', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Many of the PSG data samples that were collected the night of surgery were not interpretable and poor quality.'}, {'type': 'SECONDARY', 'title': 'Burst Suppression Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MGH Surgery Patients', 'description': 'PSG and EEG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.\n\nPSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance. EEG data to be collected in the Operating room during surgery.'}], 'classes': [{'title': 'Patients screened positive for delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.43'}]}]}, {'title': 'Patients screened negative for delirium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Length of surgery (2-12 hours)', 'description': 'Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 14 EEG recordings were analyzed. EEG recordings for other patients were not analyzed due to poor quality or lack of recording due to electronic or manual error during surgery.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MGH Surgery Patients', 'description': 'PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.\n\nPSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'Completed Baseline Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'Completed PSG', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Found Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MGH Surgery Patients', 'description': 'PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.\n\nPSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Based on number of patients who enrolled.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '72', 'spread': '5.98', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Based on number of patients who enrolled.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Based on number of patients who enrolled.', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Based on number of patients who completed the baseline assessment.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Based on number of participants who completed the baseline assessment. Ethnicity data was collected during the baseline assessment.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Based on number of patients who completed the baseline assessment.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Based on number of participants who completed the baseline assessment. Race data was collected during the baseline assessment.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '38 Patients enrolled in the study. 32 Patients completed the baseline assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-05', 'size': 199913, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-09T08:12', 'hasProtocol': True}, {'date': '2019-02-25', 'size': 304527, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-07-09T08:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-17', 'studyFirstSubmitDate': '2018-04-05', 'resultsFirstSubmitDate': '2020-07-09', 'studyFirstSubmitQcDate': '2018-04-12', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-02', 'studyFirstPostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association Between Sleep and POD', 'timeFrame': 'Night before surgery, approximately 13 hours', 'description': 'Duration of sleep in delirious vs non-delirious patients'}], 'secondaryOutcomes': [{'measure': 'Burst Suppression Ratio', 'timeFrame': 'Length of surgery (2-12 hours)', 'description': 'Burst suppression ratio during cardiopulmonary bypass. EEG recordings from the operating room were collected and analyzed for burst suppression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium']}, 'referencesModule': {'references': [{'pmid': '33759264', 'type': 'DERIVED', 'citation': 'Ibala R, Mekonnen J, Gitlin J, Hahm EY, Ethridge BR, Colon KM, Marota S, Ortega C, Pedemonte JC, Cobanaj M, Chamadia S, Qu J, Gao L, Barbieri R, Akeju O. A polysomnography study examining the association between sleep and postoperative delirium in older hospitalized cardiac surgical patients. J Sleep Res. 2021 Oct;30(5):e13322. doi: 10.1111/jsr.13322. Epub 2021 Mar 24.'}]}, 'descriptionModule': {'briefSummary': "The investigators are performing this research study to understand the role of sleep disturbance on the incidence/severity of delirium after surgery. The investigators will study the brain using a polysomnography device (PSG), which records the brain's electrical activity during sleep.", 'detailedDescription': 'During this study, PSG recordings will be collected and a sleep questionnaire will be administered to participants on the night before surgery in order to establish level of preexisting sleep disturbance. Delirium assessments will be conducted during the postoperative period. On postoperative days 0 and 1, blood will be collected for analysis. Further cognitive, quality of life and pain questionnaires will be administered perioperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients over the age of 60 scheduled for a surgical procedure at MGH', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 60 years of age\n* Inpatient and scheduled for surgical procedure at MGH\n\nExclusion Criteria:\n\n* Blindness, deafness or the inability to speak English\n* Inability to provide informed consent\n\nObjective Drop Criteria\n\n* Post-operative intubation greater than 24 hours'}, 'identificationModule': {'nctId': 'NCT03498560', 'briefTitle': 'Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium', 'orgStudyIdInfo': {'id': '2018P000480'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MGH Surgery Patients', 'description': 'PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH.', 'interventionNames': ['Device: PSG']}], 'interventions': [{'name': 'PSG', 'type': 'DEVICE', 'description': 'PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.', 'armGroupLabels': ['MGH Surgery Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anaesthesia', 'investigatorFullName': 'Oluwaseun Johnson-Akeju, MD, MMSc', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}