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

September 29, 2016 updated by: University of Chicago

Extended Work Schedules and Health: Role of Sleep Loss

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University Of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 2, 2009

First Posted (Estimate)

October 5, 2009

Study Record Updates

Last Update Posted (Estimate)

October 3, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11403A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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