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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00272233
Other study ID # HIC26414
Secondary ID NIH NHLBI K24 04
Status Completed
Phase Phase 1
First received January 3, 2006
Last updated March 19, 2007
Start date December 2004
Est. completion date June 2005

Study information

Verified date January 2006
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Yale University School of MedicineUnited States: National Heart Lung and Blood Institute
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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 Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Locations

Country Name City State
United States Yale University School of Medicine New Haven Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Yale University National Center for Research Resources (NCRR), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

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