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

NCT ID: NCT00272233

Last Updated: 2007-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Deprivation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stuart D Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIH NHLBI K24 04024

Identifier Type: -

Identifier Source: secondary_id

HIC26414

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sleep Extension and Blood Pressure
NCT02929810 COMPLETED NA
Synovial Fluid Sleep Study
NCT04688099 COMPLETED
Sleep Survey for Medical Trainees
NCT06706453 ENROLLING_BY_INVITATION