Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Predictors of the Metabolic Effect of Sleep Loss (SDBO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00965783
First received: August 25, 2009
Last updated: September 4, 2013
Last verified: September 2013

August 25, 2009
September 4, 2013
June 2007
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00965783 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Predictors of the Metabolic Effect of Sleep Loss
Predictors of the Metabolic Effect of Sleep Loss

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
  • Apnea
  • Obstructive Sleep Apnea (OSA)
  • Obesity
  • Other: Restriction
    Time in bed for each subject is restricted by two hours per night for 4 nights
  • Other: Extension
    Bedtime is extended by 2 hours per night for 4 nights
  • Experimental: 1
    Sleep time restriction
    Intervention: Other: Restriction
  • Experimental: 2
    Sleep time extension
    Intervention: Other: Extension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
25 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00965783
#15207A, 1 RO1 IIL075025
No
University of Chicago
University of Chicago
Not Provided
Not Provided
University of Chicago
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP