Metabolic Study of Sleep Apnea in Men and Women

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The University of Chicago

Status

Completed

Conditions

Obstructive Sleep Apnea (OSA)

Treatments

Device: CPAP

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00706511
P50HD057796 (U.S. NIH Grant/Contract)
15870

Details and patient eligibility

About

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

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

27 participants in 2 patient groups

Group with OSA
Experimental group
Description:
Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.
Treatment:
Device: CPAP
Group without OSA
No Intervention group
Description:
Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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