Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents - Tabular View

Tracking Information

First Received Date ^ICMJE

January 3, 2006

Last Updated Date

March 19, 2007

Start Date ^ICMJE

December 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00272233 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents

Official Title ^ICMJE

Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents

Brief Summary

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.

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 Phase

Phase I

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Natural History, Longitudinal, Defined Population, Prospective Study

Condition ^ICMJE

Sleep Deprivation

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00272233

Responsible Party

Study ID Numbers ^ICMJE

HIC26414, NIH NHLBI K24 04024

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)

Investigators ^ICMJE

Principal Investigator:

Stuart D Katz, MD

Yale University

Information Provided By

Yale University

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP