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Extended Work Schedules, Sleep Loss and Health (EW and EWD)

This study has been completed.
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00989534
First received: October 1, 2009
Last updated: October 2, 2009
Last verified: October 2009
History of Changes
  Purpose

This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk of diabetes, independently of the amount of sleep loss.


Condition Intervention
Sleep
 Behavioral: Fixed restricted bedtimes
Behavioral: Sleep restriction with circadian misalignment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Extended Work Schedules and Health: Role of Sleep Loss

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by University of Chicago:

Study Start Date: January 2003
Study Completion Date: September 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sleep restriction without circadian misalignment
Sleep restriction without circadian misalignment
 Behavioral: Fixed restricted bedtimes
Sleep restricted to 5 hours per night for 8 nights
Experimental: Sleep restriction with circadian misalignment Behavioral: Sleep restriction with circadian misalignment
Sleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep

  Eligibility

Ages Eligible for Study:   21 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • normal healthy men and women between the ages of 21 years and 39 years (inclusive) with normal weight (i.e., body mass index under 28 kg/m2 in men, 27 kg/m2 in women)
  • normal findings on clinical examination, normal results on routine laboratory tests, normal EKG, normal glucose tolerance test, negative pregnancy test for women
  • no personal history of psychiatric or endocrine illness
  • no personal history of sleep disorder, usual total sleep time of at least 7 hours
  • only female volunteers with normal ovulatory cycles will be included

Exclusion Criteria:

  • subjects with irregular life habits (shiftworkers and subjects having traveled across time zones less than one month prior to the beginning of the baseline study)
  • subjects taking any medication (including hormonal contraceptive therapy), and smokers are excluded
  • subjects with significant sleep apnea (apnea index above 10) or significant arousal-associated periodic leg movements are excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989534

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
  More Information

No publications provided

Responsible Party: Eve Van Cauter, PhD, Professor, The University of Chicago
ClinicalTrials.gov Identifier: NCT00989534     History of Changes
Other Study ID Numbers: 11403A
Study First Received: October 1, 2009
Last Updated: October 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
shift work
diabetes
Affects of shift work and sleep loss on health

ClinicalTrials.gov processed this record on May 19, 2013