Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-24 @ 5:06 AM
Study NCT ID:
NCT00989534
Status:
COMPLETED
Last Update Posted:
2016-10-03
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended Work Schedules, Sleep Loss and Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2009-10-01', 'studyFirstSubmitQcDate': '2009-10-02', 'lastUpdatePostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['shift work', 'diabetes', 'Affects of shift work and sleep loss on health'], 'conditions': ['Sleep']}, 'referencesModule': {'references': [{'pmid': '24458353', 'type': 'RESULT', 'citation': 'Leproult R, Holmback U, Van Cauter E. Circadian misalignment augments markers of insulin resistance and inflammation, independently of sleep loss. Diabetes. 2014 Jun;63(6):1860-9. doi: 10.2337/db13-1546. Epub 2014 Jan 23.'}, {'pmid': '27271308', 'type': 'RESULT', 'citation': 'Grimaldi D, Carter JR, Van Cauter E, Leproult R. Adverse Impact of Sleep Restriction and Circadian Misalignment on Autonomic Function in Healthy Young Adults. Hypertension. 2016 Jul;68(1):243-50. doi: 10.1161/HYPERTENSIONAHA.115.06847. Epub 2016 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk of diabetes, independently of the amount of sleep loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal healthy men and women between the ages of 21 years and 39 years (inclusive) with normal weight (i.e., body mass index under 28 kg/m2 in men, 27 kg/m2 in women)\n* normal findings on clinical examination, normal results on routine laboratory tests, normal EKG, normal glucose tolerance test, negative pregnancy test for women\n* no personal history of psychiatric or endocrine illness\n* no personal history of sleep disorder, usual total sleep time of at least 7 hours\n* only female volunteers with normal ovulatory cycles will be included\n\nExclusion Criteria:\n\n* subjects with irregular life habits (shiftworkers and subjects having traveled across time zones less than one month prior to the beginning of the baseline study)\n* subjects taking any medication (including hormonal contraceptive therapy), and smokers are excluded\n* subjects with significant sleep apnea (apnea index above 10) or significant arousal-associated periodic leg movements are excluded'}, 'identificationModule': {'nctId': 'NCT00989534', 'acronym': 'EW and EWD', 'briefTitle': 'Extended Work Schedules, Sleep Loss and Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Extended Work Schedules and Health: Role of Sleep Loss', 'orgStudyIdInfo': {'id': '11403A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep loss and circadian alignment', 'description': 'Sleep restriction without circadian misalignment', 'interventionNames': ['Behavioral: Fixed restricted bedtimes']}, {'type': 'EXPERIMENTAL', 'label': 'Sleep loss and circadian misalignment', 'interventionNames': ['Behavioral: Sleep restriction with circadian misalignment']}], 'interventions': [{'name': 'Fixed restricted bedtimes', 'type': 'BEHAVIORAL', 'description': 'Sleep restricted to 5 hours per night for 8 nights', 'armGroupLabels': ['Sleep loss and circadian alignment']}, {'name': 'Sleep restriction with circadian misalignment', 'type': 'BEHAVIORAL', 'description': 'Sleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep', 'armGroupLabels': ['Sleep loss and circadian misalignment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}