Metabolic Study of Sleep Apnea in Men and Women

NCT ID: NCT00706511

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2012-08-22

Brief 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

Obstructive Sleep Apnea (OSA)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group with OSA

Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol.

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

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

Group without OSA

Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CPAP

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

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eve Van Cauter, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism

Chicago, Illinois, United States

Countries

United States

References

Tasali E, Leproult R, Ehrmann DA, Van Cauter E. Slow-wave sleep and the risk of type 2 diabetes in humans. Proc Natl Acad Sci U S A. 2008 Jan 22;105(3):1044-9. doi: 10.1073/pnas.0706446105. Epub 2008 Jan 2.

Reference Type: BACKGROUND

PMID: 18172212 (View on PubMed)

Tasali E, Van Cauter E, Ehrmann DA. Relationships between sleep disordered breathing and glucose metabolism in polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Jan;91(1):36-42. doi: 10.1210/jc.2005-1084. Epub 2005 Oct 11.

Reference Type: BACKGROUND

PMID: 16219719 (View on PubMed)

Tasali E, Mokhlesi B, Van Cauter E. Obstructive sleep apnea and type 2 diabetes: interacting epidemics. Chest. 2008 Feb;133(2):496-506. doi: 10.1378/chest.07-0828.

Reference Type: BACKGROUND

PMID: 18252916 (View on PubMed)

Knutson KL, Spiegel K, Penev P, Van Cauter E. The metabolic consequences of sleep deprivation. Sleep Med Rev. 2007 Jun;11(3):163-78. doi: 10.1016/j.smrv.2007.01.002. Epub 2007 Apr 17.

Reference Type: BACKGROUND

PMID: 17442599 (View on PubMed)

Van Cauter E, Holmback U, Knutson K, Leproult R, Miller A, Nedeltcheva A, Pannain S, Penev P, Tasali E, Spiegel K. Impact of sleep and sleep loss on neuroendocrine and metabolic function. Horm Res. 2007;67 Suppl 1:2-9. doi: 10.1159/000097543. Epub 2007 Feb 15.

Reference Type: BACKGROUND

PMID: 17308390 (View on PubMed)

Knutson KL, Ryden AM, Mander BA, Van Cauter E. Role of sleep duration and quality in the risk and severity of type 2 diabetes mellitus. Arch Intern Med. 2006 Sep 18;166(16):1768-74. doi: 10.1001/archinte.166.16.1768.

Reference Type: BACKGROUND

PMID: 16983057 (View on PubMed)

Latta F, Leproult R, Tasali E, Hofmann E, L'Hermite-Baleriaux M, Copinschi G, Van Cauter E. Sex differences in nocturnal growth hormone and prolactin secretion in healthy older adults: relationships with sleep EEG variables. Sleep. 2005 Dec;28(12):1519-24. doi: 10.1093/sleep/28.12.1519.

Reference Type: BACKGROUND

PMID: 16408410 (View on PubMed)

Related Links

http://www.uchospitals.edu/specialties/pulmonary/sleep-disorders/index.html

University of Chicago Sleep Disorders Center

Other Identifiers

P50HD057796

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15870

Identifier Type: -

Identifier Source: org_study_id