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Predictors of the Metabolic Effect of Sleep Loss (SDBO)

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ClinicalTrials.gov Identifier: NCT00965783
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.


Condition or disease Intervention/treatment Phase
Apnea Obstructive Sleep Apnea (OSA) Obesity Other: Restriction Other: Extension Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Predictors of the Metabolic Effect of Sleep Loss
Study Start Date : June 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965783


Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00965783     History of Changes
Other Study ID Numbers: #15207A
1 RO1 IIL075025
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

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

Additional relevant MeSH terms:
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases