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
  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:


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 ]

Enrollment: 30
Study Start Date: June 2007
Study Completion Date: December 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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: September 4, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014