Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-03-13 @ 8:09 PM
Study NCT ID:
NCT00272233
Status:
COMPLETED
Last Update Posted:
2007-03-20
First Post:
2006-01-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'completionDateStruct': {'date': '2005-06'}, 'lastUpdateSubmitDate': '2007-03-19', 'studyFirstSubmitDate': '2006-01-03', 'studyFirstSubmitQcDate': '2006-01-03', 'lastUpdatePostDateStruct': {'date': '2007-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-04', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Inflammation Mediators [D23.469]', 'Cardiovascular Physiologic Phenomena [G09.330.553]'], 'conditions': ['Sleep Deprivation']}, 'descriptionModule': {'briefSummary': 'Work requirements for medical trainees result in substantial sleep loss. Sleep loss has been associated with increased levels of certain inflammatory hormones that could have negative impact on blood vessel function. The purpose of this study is to determine the effects of sleep loss on blood hormone levels and blood vessel function in medical trainees.', 'detailedDescription': 'Context: Sleep loss is associated with increased blood levels of interleukin-6 (IL-6) and C-reactive protein (CRP). Medical residents are often deprived of normal sleep during extended work shifts, but the effects of work-related sleep loss on biomarkers of vascular inflammation and function are unknown.\n\nObjective: We sought to test the hypothesis that sleep loss during extended work shifts during medical training is associated with increased circulating levels of pro-inflammatory biomarkers and evidence of vascular dysfunction.\n\nDesign: Outcome measures were assessed after extended 30-hour work shifts and non-extended 6-hour work shifts in a single-blind, randomized crossover design.\n\nSetting: University hospital medical intensive care unit\n\nPatients or Other Participants: Twenty-two healthy medical residents were studied during a medical intensive care unit rotation.\n\nMain Outcome Measure(s): Sleep related cytokines (interleukin-6 and tumor necrosis factor), serum markers of vascular inflammation (C-reactive protein), and flow-mediated dilation in the brachial artery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical resident in MICU rotation\n* Non-smoker\n* Body mass index \\<28 kg/m2\n\nExclusion Criteria:\n\n* Systolic blood pressure \\>140 mmHg; Diastolic blood pressure \\>90 mmHg\n* Known history of diabetes mellitus, hypertension, hyperlipidemia\n* Known history of acute or chronic inflammatory or infectious disease\n* Known history of sleep disturbance unrelated to work\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00272233', 'briefTitle': 'Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents', 'orgStudyIdInfo': {'id': 'HIC26414'}, 'secondaryIdInfos': [{'id': 'NIH NHLBI K24 04024'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Stuart D Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}]}}}