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EW and EWD: Extended Work Schedules, Sleep Loss and Health

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT00989534
Collaborator
(none)
49
Enrollment
1
Location
2
Arms
80
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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 Phase
  • Behavioral: Fixed restricted bedtimes
  • Behavioral: Sleep restriction with circadian misalignment
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2003
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Sep 1, 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

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 39 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 The University of Chicago Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT00989534
    Other Study ID Numbers:
    • 11403A
    First Posted:
    Oct 5, 2009
    Last Update Posted:
    Oct 3, 2016
    Last Verified:
    Sep 1, 2016
    Keywords provided by University of Chicago
    shift work
    diabetes
    Affects of shift work and sleep loss on health

    Study Results

    No Results Posted as of Oct 3, 2016