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

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ClinicalTrials.gov Identifier: NCT00989534
Recruitment Status : Completed
First Posted : October 5, 2009
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Sleep Behavioral: Fixed restricted bedtimes Behavioral: Sleep restriction with circadian misalignment

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Extended Work Schedules and Health: Role of Sleep Loss
Study Start Date : January 2003
Primary Completion Date : December 2007
Study Completion Date : September 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: Sleep loss and circadian alignment
Sleep restriction without circadian misalignment
Behavioral: Fixed restricted bedtimes
Sleep restricted to 5 hours per night for 8 nights
Experimental: Sleep loss and circadian misalignment Behavioral: Sleep restriction with circadian misalignment
Sleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
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

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): NCT00989534


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