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Predictors of the Metabolic Effect of Sleep Loss (SDBO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Chicago.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00965783
First received: August 25, 2009
Last updated: October 1, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention
Apnea
Obstructive Sleep Apnea (OSA)
Obesity
 Other: Restriction
Other: Extension

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Predictors of the Metabolic Effect of Sleep Loss

Resource links provided by NLM:

MedlinePlus related topics: Obesity Sleep Apnea
U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 67
Study Start Date: June 2007
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965783

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: NCT00965783     History of Changes
Other Study ID Numbers: #15207A, 1 RO1 IIL075025
Study First Received: August 25, 2009
Last Updated: October 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Sleep, Apnea, OSA, obese, middle-aged

Additional relevant MeSH terms:
Apnea
Obesity
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013