- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00272233
Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents
Study Overview
Status
Conditions
Detailed Description
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.
Objective: 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.
Design: Outcome measures were assessed after extended 30-hour work shifts and non-extended 6-hour work shifts in a single-blind, randomized crossover design.
Setting: University hospital medical intensive care unit
Patients or Other Participants: Twenty-two healthy medical residents were studied during a medical intensive care unit rotation.
Main 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.
Study Type
Enrollment
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale University School Of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medical resident in MICU rotation
- Non-smoker
- Body mass index <28 kg/m2
Exclusion Criteria:
- Systolic blood pressure >140 mmHg; Diastolic blood pressure >90 mmHg
- Known history of diabetes mellitus, hypertension, hyperlipidemia
- Known history of acute or chronic inflammatory or infectious disease
- Known history of sleep disturbance unrelated to work
- Pregnancy
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stuart D Katz, MD, Yale University
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIC26414
- NIH NHLBI K24 04024
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