Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-30 @ 1:23 AM
Study NCT ID:
NCT00786357
Status:
COMPLETED
Last Update Posted:
2010-06-23
First Post:
2008-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Enhancement Training Study for Experienced Shiftworkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020178', 'term': 'Sleep Disorders, Circadian Rhythm'}], 'ancestors': [{'id': 'D021081', 'term': 'Chronobiology Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-22', 'studyFirstSubmitDate': '2008-11-04', 'studyFirstSubmitQcDate': '2008-11-04', 'lastUpdatePostDateStruct': {'date': '2010-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'actigraphy measures of sleep', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'subjective measures of sleep and well-being', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['shift-work', 'sleep', 'nurse', 'relaxation'], 'conditions': ['Shift-Work Sleep Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a modified version of the Sleep Enhancement Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and quality of life in experienced shift-working nurses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking nurses\n* scheduled to work at least 2 consecutive night shifts per week during the next 3 months\n* ≥40 years of age\n* experiencing disturbed sleep related to night-shift\n\nExclusion Criteria:\n\n* current diagnosis of sleep disorder or affective illness'}, 'identificationModule': {'nctId': 'NCT00786357', 'acronym': 'SETS-exp', 'briefTitle': 'Sleep Enhancement Training Study for Experienced Shiftworkers', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Sleep Enhancement Training Study for Experienced Shiftworkers', 'orgStudyIdInfo': {'id': 'SETS-exp'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Behavioral: NIOSH shiftwork booklet', 'Behavioral: Sleep Enhancement Training System']}], 'interventions': [{'name': 'NIOSH shiftwork booklet', 'type': 'BEHAVIORAL', 'description': 'weekly readings about coping with shiftwork', 'armGroupLabels': ['Intervention']}, {'name': 'Sleep Enhancement Training System', 'type': 'BEHAVIORAL', 'description': '4 week program of readings and relaxation programs', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Christopher R. Alsten, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inner Health, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Christopher Alsten, PhD, Executive Vice President', 'oldOrganization': 'Inner Health, Inc'}}}}