Predictors of the Metabolic Effect of Sleep Loss (SDBO)

September 4, 2013 updated by: University of Chicago

To test whether baseline levels of slow wave activity (SWA) during sleep are lower in obese adults, and even lower in persons with sleep disordered breathing (SDB) compared to lean adults.

To compare levels of SWA in individuals in relation to their sleep time, blood pressure, heart rate, and markers of glucose metabolism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

25 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy,
  • normal sleepers,
  • lean, overweight,
  • obese,
  • pre menopausal

Exclusion Criteria:

  • no shift workers or night-shift workers,
  • no mental health disorders,
  • no acute or chronic health conditions (stable, well controlled hypertension are accepted),
  • no hormonal treatments,
  • no substances that may interfere with sleep,
  • problems with sleep

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Sleep time restriction
Other: Restriction
Time in bed for each subject is restricted by two hours per night for 4 nights
Experimental: 2
Sleep time extension
Other: Extension
Bedtime is extended by 2 hours per night for 4 nights

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between SWA, sleep duration,sleep architecture, and biomarkers of the metabolic syndrome in lean, obese with and without obstructive sleep apnea.
Time Frame: study completion
study completion

Collaborators and Investigators

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

Sponsor

University of Chicago

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

June 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (Estimate)

August 26, 2009

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #15207A
  • 1 RO1 IIL075025

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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