This trial is active, not recruiting.

Condition obstructive sleep apnea (osa)
Treatment cpap
Sponsor University of Chicago
Collaborator Duke University
Start date December 2007
End date August 2017
Trial size 60 participants
Trial identifier NCT00706511, 15870, 1P50HD057796


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.
CPAP (continuous positive airway pressure) treatment at home for 6 weeks
(No Intervention)
Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol

Primary Outcomes

Sleep recording/polysomnography
time frame: After treatment (6 weeks)

Secondary Outcomes

Frequently sampled IVGTT
time frame: After treatment (6 weeks)

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

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)

Additional Information

Official title Sleep and Metabolism in Obesity: Impact of Gender
Principal investigator Eve Van Cauter, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University of Chicago.