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
  Purpose

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


Condition Intervention
Obstructive Sleep Apnea (OSA)
Device: CPAP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sleep and Metabolism in Obesity: Impact of Gender

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Sleep recording/polysomnography [ Time Frame: After treatment (6 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequently sampled IVGTT [ Time Frame: After treatment (6 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2007
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: CPAP
CPAP (continuous positive airway pressure) treatment at home for 6 weeks
No Intervention: 2
Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT00706511

Locations
United States, Illinois
University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Duke University
Investigators
Principal Investigator: Eve Van Cauter, Ph.D. University of Chicago
  More Information

Additional Information:
Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00706511     History of Changes
Other Study ID Numbers: 15870, 1P50HD057796
Study First Received: June 25, 2008
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
OSA
Diabetes
Metabolism
Gender

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

ClinicalTrials.gov processed this record on July 10, 2014