Cardiometabolic Risk of Shiftwork

NCT01264913 | Terminated DMC

• 1 other identifier: 09-049-A
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation; Circadian Dysregulation; Shift-Work Sleep Disorder

Study Arms (2)

Shift Workers

Behavioral: sleep extension & circadian alignment

Day Workers

Behavioral: sleep extension & circadian alignment

Interventions

sleep extension & circadian alignment BEHAVIORAL

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

Also known as: SWI intervention

Day Workers; Shift Workers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Sleep Deprivation; Chronobiology Disorders; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Occupational Diseases

Study Officials

• Eve Van Cauter

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 22, 2010
• Study Start: August 1, 2009
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 3, 2016

Record last verified: 2016-09

Locations

US (1)