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| ID | Type | Description | Link |
|---|---|---|---|
| P50HD057796 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in men and women.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with OSA | Experimental | Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. |
|
| Group without OSA | No Intervention | Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | CPAP (continuous positive airway pressure) treatment at home for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography - Apnea-hypopnea Index (AHI) | apnea-hypopnea index: number of apneas and hypopneas per hour of recording; a measure of the severity of obstructive sleep apnea; varies from min=0 to max=120; AHI between 0 and <5: no significant sleep apnea; AHI between 5 and <15: mild sleep apnea; AHI between 15 and <30: moderate sleep apnea; AHI of 30 and above: severe sleep apnea. | After 6 weeks of CPAP (Treatment) |
| Polysomnography - Minutes of N3 Stage | Stage N3, sometimes referred to as "delta sleep" or "slow wave sleep", is characterized by slow waves in the electro-encephalogram (EEG) that reflect synchronization of firing of cortical neurons. N3 sleep is considered the most restorative stage of sleep for both the brain and the rest of the body. | After 6 weeks of CPAP (Treatment) |
| Polysomnography - Minutes of REM Stage | After 6 weeks of CPAP (Treatment) | |
| Polysomnography - Sleep Efficiency | Sleep efficiency: a measure of objective sleep quality; calculated from the polygraphic sleep recording as the ratio of time spent asleep during the scheduled sleep period to total scheduled sleep period. Expressed in %. Varies from 0% (the subject did not sleep at all) to 100% (the subject spent the entire scheduled sleep period asleep). | After 6 weeks of CPAP (Treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| IVGTT (Intravenous Tolerance Test) - Sensitivity Index (SI) | Sensitivity Index (SI): a measure of how much insulin the body needs to metabolize a given amount of glucose. SI is calculated using a mathematical model describing the profiles of blood glucose and serum insulin after intravenous glucose injection. SI varies from 0 to an undefined upper limit but generally under 20. Higher values of SI represent a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eve Van Cauter, Ph.D. | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18172212 | Background | 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. | |
| 16219719 | Background | 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. |
| Label | URL |
|---|---|
| University of Chicago Sleep Disorders Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Men 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. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks |
| FG001 | Women 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. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks |
| FG002 | Men Without OSA | Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol |
| FG003 | Women Without OSA | Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Men 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. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks |
| BG001 | Women With OSA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Polysomnography - Apnea-hypopnea Index (AHI) | apnea-hypopnea index: number of apneas and hypopneas per hour of recording; a measure of the severity of obstructive sleep apnea; varies from min=0 to max=120; AHI between 0 and <5: no significant sleep apnea; AHI between 5 and <15: mild sleep apnea; AHI between 15 and <30: moderate sleep apnea; AHI of 30 and above: severe sleep apnea. | One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart) | Posted | Mean | Standard Deviation | units on a scale | After 6 weeks of CPAP (Treatment) |
|
Up to 24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eve Van Cauter, PhD | University of Chicago | 773-702-0169 | evcauter@bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D003920 | Diabetes Mellitus |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| After treatment (6 weeks) |
| IVGTT (Intravenous Tolerance Test) - Acute Insulin Response | Acute Insulin Response is calculated as the area under the insulin curve for the first 19 minutes after intravenous glucose injection. "Area under the insulin curve" is expressed in pmol x min/L. | After treatment (6 weeks) |
| IVGTT (Intravenous Tolerance Test) - Disposition Index (DI) | Disposition Index (DI) is the product of sensitivity index (SI) by the amount of insulin secreted in response to blood glucose levels. It is a marker of the risk of type 2 diabetes. Low DI reflects a high risk of diabetes. DI can vary from 0 to an undefined upper limit. The physiological range for the Disposition Index is 500 to 5,000. Higher values represent a better outcome. | After treatment (6 weeks) |
| 18252916 | Background | 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. |
| 17442599 | Background | 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. |
| 17308390 | Background | 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. |
| 16983057 | Background | 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. |
| 16408410 | Background | 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. |
Obese men and pre-menopausal women with OSA will receive 6 weeks of CPAP treatment, and assessed with a 3-day experimental protocol. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks |
| BG002 | Men Without OSA | Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol |
| BG003 | Women Without OSA | Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Women 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. CPAP: CPAP (continuous positive airway pressure) treatment at home for 6 weeks |
| OG002 | Men Without OSA | Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol |
| OG003 | Women Without OSA | Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol |
|
|
| Primary | Polysomnography - Minutes of N3 Stage | Stage N3, sometimes referred to as "delta sleep" or "slow wave sleep", is characterized by slow waves in the electro-encephalogram (EEG) that reflect synchronization of firing of cortical neurons. N3 sleep is considered the most restorative stage of sleep for both the brain and the rest of the body. | One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart) | Posted | Mean | Standard Deviation | minutes | After 6 weeks of CPAP (Treatment) |
|
|
|
| Primary | Polysomnography - Minutes of REM Stage | One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart) | Posted | Mean | Standard Deviation | minutes | After 6 weeks of CPAP (Treatment) |
|
|
|
| Primary | Polysomnography - Sleep Efficiency | Sleep efficiency: a measure of objective sleep quality; calculated from the polygraphic sleep recording as the ratio of time spent asleep during the scheduled sleep period to total scheduled sleep period. Expressed in %. Varies from 0% (the subject did not sleep at all) to 100% (the subject spent the entire scheduled sleep period asleep). | One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart) | Posted | Mean | Standard Deviation | score on a scale | After 6 weeks of CPAP (Treatment) |
|
|
|
| Secondary | IVGTT (Intravenous Tolerance Test) - Sensitivity Index (SI) | Sensitivity Index (SI): a measure of how much insulin the body needs to metabolize a given amount of glucose. SI is calculated using a mathematical model describing the profiles of blood glucose and serum insulin after intravenous glucose injection. SI varies from 0 to an undefined upper limit but generally under 20. Higher values of SI represent a better outcome. | One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart) | Posted | Mean | Standard Deviation | score on a scale | After treatment (6 weeks) |
|
|
|
| Secondary | IVGTT (Intravenous Tolerance Test) - Acute Insulin Response | Acute Insulin Response is calculated as the area under the insulin curve for the first 19 minutes after intravenous glucose injection. "Area under the insulin curve" is expressed in pmol x min/L. | One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart) | Posted | Mean | Standard Deviation | pmol x min/L | After treatment (6 weeks) |
|
|
|
| Secondary | IVGTT (Intravenous Tolerance Test) - Disposition Index (DI) | Disposition Index (DI) is the product of sensitivity index (SI) by the amount of insulin secreted in response to blood glucose levels. It is a marker of the risk of type 2 diabetes. Low DI reflects a high risk of diabetes. DI can vary from 0 to an undefined upper limit. The physiological range for the Disposition Index is 500 to 5,000. Higher values represent a better outcome. | One participant (a men with OSA) was excluded in the analysis because he did not complete the study. (See the participant flow chart) | Posted | Mean | Standard Deviation | score on a scale | After treatment (6 weeks) |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Group Without OSA | Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol | 0 | 13 | 0 | 13 | 0 | 13 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012725 | Sexual Behavior |
| D001519 | Behavior |