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Cardiometabolic Risk of Shiftwork (SW)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01264913
First received: December 13, 2010
Last updated: September 4, 2013
Last verified: January 2013
  Purpose

The overall goal of the present application is to test the hypothesis that shift workers, who are chronically exposed to circadian misalignment and sleep loss, have a higher cardio-metabolic risk than day workers, and that the accumulated sleep debt and the degree of circadian misalignment both predict their elevated cardio-metabolic risk.


Condition
Sleep Deprivation
Circadian Dysregulation
Shift-Work Sleep Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Cardiometabolic Risk of ShiftWork: Sleep Loss vs.Circadian Disruption

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Estimated Enrollment: 90
Study Start Date: August 2009
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Shift Workers
Day Workers

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We will enroll 44-46 regular day workers (work hours between 7:00 a.m. and 7:00 p.m. on all work days) and 44-46 shift workers on rotating schedules (changing shift at lease once a week and having work hours between 7:00 p.m. and 7:00 a.m. on at least 10 days per month). Both groups of subjects will work at least 30 hours per week at the University of Chicago, University of Chicago Medical Center, or other Chicago area medical center and have maintained their work schedule for at least 6 months.

Criteria

Inclusion Criteria:

  • Day workers and shift workers at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center who have maintained their work schedule (at least 30 hours/week) for at least 6 months.
  • Individuals who have been shift workers for less than 10 years; body mass index <40 kg/m2;
  • No major illness
  • No history of psychiatric, endocrine, cardiac or sleep disorders
  • Those with hypertension or dyslipidemia will be included if these conditions are controlled by a stable treatment.
  • Women taking oral contraceptive or hormonal replacement therapy will be included only if they plan to stay on a stable regimen throughout the study.
  • Age must be between 18 and 50 years

Exclusion Criteria:

  • Individuals who have worked at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center in their current position for less than 6 months.
  • Individuals who have been shift workers for more than 10 years
  • BMI>40 kg/m2
  • Individuals with a major illness (e.g. diabetes, sleep disorder)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264913

Contacts
Contact: Lauran DeCeault 773-834-3144 ldeceaul@medicine.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Eve Van Cauter, PhD         
Principal Investigator: Eve Van Cauter, PhD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Eve Van Cauter University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01264913     History of Changes
Other Study ID Numbers: 09-049-A
Study First Received: December 13, 2010
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronobiology Disorders
Parasomnias
Sleep Deprivation
Sleep Disorders
Sleep Disorders, Circadian Rhythm
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Occupational Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 23, 2014