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Cardiometabolic Risk of Shiftwork (SW)

This study has been terminated.
(impossible to retain participants in 3-year longitudinal study)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01264913
First received: December 13, 2010
Last updated: September 29, 2016
Last verified: September 2016
  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 Intervention
Sleep Deprivation
Circadian Dysregulation
Shift-Work Sleep Disorder
Behavioral: sleep extension & circadian alignment

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

Further study details as provided by University of Chicago:

Enrollment: 64
Study Start Date: August 2009
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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

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 
Study First Received: December 13, 2010
Last Updated: September 29, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 08, 2016