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Cardiometabolic Risk of Shiftwork (SW)

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ClinicalTrials.gov Identifier: NCT01264913
Recruitment Status : Terminated (impossible to retain participants in 3-year longitudinal study)
First Posted : December 22, 2010
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Sleep Deprivation Circadian Dysregulation Shift-Work Sleep Disorder Behavioral: sleep extension & circadian alignment

Study Design

Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Cardiometabolic Risk of ShiftWork: Sleep Loss vs.Circadian Disruption
Study Start Date : August 2009
Primary Completion Date : March 2015
Study Completion Date : March 2015
Groups and Cohorts

Group/Cohort Intervention/treatment
Shift Workers Behavioral: sleep extension & circadian alignment
Both groups of workers will undergo a 1-week period of fixed bedtimes, light-dark cycles and mealtimes in the laboratory to pay the sleep debt and align the circadian system
Other Name: SWI intervention
Day Workers Behavioral: sleep extension & circadian alignment
Both groups of workers will undergo a 1-week period of fixed bedtimes, light-dark cycles and mealtimes in the laboratory to pay the sleep debt and align the circadian system
Other Name: SWI intervention


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264913


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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01264913     History of Changes
Other Study ID Numbers: 09-049-A
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016

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