Metabolic Study of Sleep Apnea in Men and Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00706511
First received: June 25, 2008
Last updated: May 16, 2014
Last verified: May 2014

June 25, 2008
May 16, 2014
December 2007
August 2017   (final data collection date for primary outcome measure)
Sleep recording/polysomnography [ Time Frame: After treatment (6 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00706511 on ClinicalTrials.gov Archive Site
Frequently sampled IVGTT [ Time Frame: After treatment (6 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Metabolic Study of Sleep Apnea in Men and Women
Sleep and Metabolism in Obesity: Impact of Gender

The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in men and women.

Obesity is a major risk factor for obstructive sleep apnea (OSA), a condition characterized by repetitive respiratory disturbances, intermittent hypoxia, sleep fragmentation by frequent microarousals and low amounts of deep slow wave sleep (SWS). Today, more than 10 million American women suffer from OSA. OSA has been identified as an independent risk factor for the metabolic syndrome. Because OSA is more prevalent in men than in women, a disproportionate number of studies of OSA and its consequences have been conducted in men. Thus, OSA has been characterized as a disorder associated with gender-based health care inequity. Recent evidence, including data from our group, suggests that reduced amounts and intensity of SWS (i.e. slow-wave activity [SWA]) may play a pivotal role in the development of metabolic and cardiovascular disturbances in obese men and women, particularly those with OSA. This project will focus on sex differences in SWA and their relationship with daytime sleepiness and metabolic vulnerability in obese men and women with and without OSA. We propose to simultaneously characterize: 1. sleep-wake regulation; 2. measures of diabetes risk; 3. measures of cardiovascular risk; and 4. profiles of sex steroids, cortisol and adipokines in a. obese men without OSA, b. obese men with OSA before and after treatment with continuous positive airway pressure (CPAP), c. obese pre-menopausal women without OSA, and d. obese pre-menopausal women with OSA before and after CPAP treatment. The completion of these interdisciplinary studies will provide a unique data set contrasting in obese women versus obese men the relationships between sleep and the metabolic syndrome, OSA and the metabolic syndrome and the impact of CPAP treatment on the metabolic syndrome. This work will provide important insights regarding the pathophysiology of OSA and its adverse consequences in obese men and women, and the basis for the development of effective sex-specific prevention and treatment strategies.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstructive Sleep Apnea (OSA)
Device: CPAP
CPAP (continuous positive airway pressure) treatment at home for 6 weeks
  • Experimental: 1
    Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.
    Intervention: Device: CPAP
  • No Intervention: 2
    Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
August 2017
August 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obese (BMI of at least 30 kg/m2)

Exclusion Criteria:

  • Clinically significant depression
  • Positive pregnancy test
  • Diagnosis of diabetes mellitus
  • Hypertension (systolic > 140 mmHg and/or diastolic > 90 mmHg) not well-controlled on stable medication with either ACE inhibitors or diuretics
  • Habitual alcohol use
  • Excessive caffeine intake of more than 300 mg/day
  • Hemoglobin < 11g/dL and/or hematocrit < 33%
  • Systemic illnesses, including heart, renal, liver, or malignant disease
  • Taking steroid preparations (including oral contraceptives), medications known to alter insulin secretion and/or action, or medications known to influence sleep during the 2 months prior to starting the study
  • Travel across time zones during the 4 weeks prior to starting the study
  • Irregular sleeping habits (including shift work)
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00706511
15870, 1P50HD057796
Yes
University of Chicago
University of Chicago
Duke University
Principal Investigator: Eve Van Cauter, Ph.D. University of Chicago
University of Chicago
May 2014

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