Cardiometabolic Risk of Shiftwork (SW)
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| ClinicalTrials.gov Identifier: NCT01264913 |
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Recruitment Status
:
Terminated
(impossible to retain participants in 3-year longitudinal study)
First Posted
: December 22, 2010
Last Update Posted
: October 3, 2016
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Sponsor:
University of Chicago
Information provided by (Responsible Party):
University of Chicago
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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 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 |
| Actual Primary Completion Date : | March 2015 |
| Actual Study Completion Date : | March 2015 |
| 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
|
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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)
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 |
| 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:
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Sleep Wake Disorders Parasomnias Sleep Deprivation Sleep Disorders, Circadian Rhythm Chronobiology Disorders Nervous System Diseases |
Neurologic Manifestations Signs and Symptoms Mental Disorders Dyssomnias Occupational Diseases |