Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-07 @ 8:43 PM
Study NCT ID:
NCT02927860
Status:
TERMINATED
Last Update Posted:
2019-01-09
First Post:
2016-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep and Activity Monitoring After Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Fitbit was not giving the necessary data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2016-10-06', 'studyFirstSubmitQcDate': '2016-10-06', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Stay', 'timeFrame': 'Until discharge, an average of 5 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of pneumonia while hospitalized', 'timeFrame': 'Until discharge, an average of 5 days'}, {'measure': 'Incidence of blood clot while hospitalized', 'timeFrame': 'Until discharge, an average of 5 days'}, {'measure': 'Incidence of deconditioning while hospitalized', 'timeFrame': 'Until discharge, an average of 5 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleep', 'exercise', 'activity'], 'conditions': ['Thoracic Surgery', 'Surgery, Thoracic']}, 'descriptionModule': {'briefSummary': 'Show by collecting sleep and activity data, outcomes after thoracic surgery are improved with better sleep and increased activity.', 'detailedDescription': 'Little is known about how sleep deprivation affects recovery after thoracic surgery. There is some evidence that in cardiac surgery, sleep disturbance can lead to delayed recovery and mental status changes in the postoperative period. There are no similar reports of studies after thoracic surgery. We think that increased activity after surgery is beneficial for a rapid recovery and prevents blood clots, pneumonia and deconditioning. Without specific data this is difficult to prove.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mayo Clinic Rochester patients undergoing thoracic surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing thoracic surgery at Mayo Clinic Rochester\n* expected to stay in hospital for at least 4 days\n* signed consent form\n\nExclusion Criteria:\n\n* Unable to provide consent'}, 'identificationModule': {'nctId': 'NCT02927860', 'briefTitle': 'Sleep and Activity Monitoring After Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Sleep and Activity Monitoring After Thoracic Surgery', 'orgStudyIdInfo': {'id': '16-006864'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fitbit', 'type': 'OTHER', 'description': "A FitBit HR monitor will be placed on patients when they arrive on the nursing unit after thoracic surgery. Sleep and activity will be monitored for the duration of the patient's hospitalization and the data from the Fitbit HR device will be downloaded by the study staff to a computer."}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Mark S Allen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mark Allen', 'investigatorAffiliation': 'Mayo Clinic'}}}}