Clinical Trials Directory

Trials / Completed

CompletedNCT00706511

Metabolic Study of Sleep Apnea in Men and Women

Sleep and Metabolism in Obesity: Impact of Gender

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
27 (actual)
Sponsor
University of Chicago · Academic / Other
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICECPAPCPAP (continuous positive airway pressure) treatment at home for 6 weeks

Timeline

Start date
2007-12-01
Primary completion
2012-08-16
Completion
2012-08-22
First posted
2008-06-27
Last updated
2020-03-24
Results posted
2020-03-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00706511. Inclusion in this directory is not an endorsement.

Metabolic Study of Sleep Apnea in Men and Women (NCT00706511) · Clinical Trials Directory