Cardiometabolic Risk of Shiftwork

Sleep Deprivation Clinical Trial

— SW  

Official title:

Cardiometabolic Risk of ShiftWork: Sleep Loss vs.Circadian Disruption

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01264913
• Other study ID #: 09-049-A
• Status: Terminated
• Phase: N/A
• First received: December 13, 2010
• Last updated: September 29, 2016
• Start date: August 2009
• Est. completion date: March 2015

Study information

• Verified date: September 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Dysregulation
• Parasomnias
• Shift-Work Sleep Disorder
• Sleep Deprivation
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

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

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States,