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

Tracking Information
First Received Date ^ICMJE	August 25, 2009
Last Updated Date	October 1, 2009
Start Date ^ICMJE	June 2007
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 25, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00965783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Predictors of the Metabolic Effect of Sleep Loss
Official Title ^ICMJE	Predictors of the Metabolic Effect of Sleep Loss
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Apnea Obstructive Sleep Apnea (OSA) Obesity
Intervention ^ICMJE	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
Study Arm (s)	Experimental: 1 Sleep time restriction Intervention: Other: Restriction Experimental: 2 Sleep time extension Intervention: Other: Extension
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	67
Completion Date	Not Provided
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	25 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00965783
Other Study ID Numbers ^ICMJE	#15207A, 1 RO1 IIL075025
Has Data Monitoring Committee	No
Responsible Party	Eve Van Cauter, PhD, Professor, The University of Chicago
Study Sponsor ^ICMJE	University of Chicago
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Chicago
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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