Obstructive Sleep Apnea (OSA)NCT00706511
Metabolic Study of Sleep Apnea in Men and Women
A study testing CPAP in people with Obstructive Sleep Apnea (OSA), run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to 22 Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obese (BMI of at least 30 kg/m2)
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Department of Medicine, Section of Endocrinology, Diabetes & Metabolism
Chicago, Illinois, 60637
About this study
Official title: Sleep and Metabolism in Obesity: Impact of Gender
The purpose of this study is to look at the metabolic (use of energy) and hormonal features of sleep problems in men and women.
Read the 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)
- Being tested
- CPAP
- Keywords
- OSA, Diabetes, Metabolism, Gender
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetes Mellitus, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
CPAP (continuous positive airway pressure) treatment at home for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CPAP |
| Group without OSA | No intervention | Obese men and pre-menopausal women without OSA will be characterized with a single 3-day experimental protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After 6 weeks of CPAP (Treatment)
Polysomnography - Minutes of REM Stage
Measured: 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).
Measured: After 6 weeks of CPAP (Treatment)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: After treatment (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startDec 2007
- Primary completion16 Aug 2012
- Study completion22 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Eve Van Cauter, Ph.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706511
- Sponsor's protocol ID
- 15870
- Other IDs
- P50HD057796
- Status last verified
- Sep 2016
- First submitted
- 25 Jun 2008
- Last updated
- 24 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 18172212Tasali 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.
PubMed 16219719Tasali 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.
PubMed 18252916Knutson 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.
PubMed 17442599Van 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.
PubMed 17308390Knutson 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.
PubMed 16983057Latta 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.
PubMed 16408410
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Metabolism in Obesity: Impact of Gender
- ClinicalTrials.gov ID
- NCT00706511
- Acronym / sponsor ID
- 15870
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- OSA, Diabetes, Metabolism, Gender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Duke University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Dec 2007 (actual)
- Primary completion
- 16 Aug 2012 (actual)
- Study completion
- 22 Aug 2012 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Posted 24 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with OSA | Experimental | Device: CPAPObese 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Obese (BMI of at least 30 kg/m2)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPCPAP (continuous positive airway pressure) treatment at home for 6 weeks | Device | Group with OSA |
Primary outcome
Polysomnography - Apnea-hypopnea Index (AHI)
Time frame: After 6 weeks of CPAP (Treatment)
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.
Polysomnography - Minutes of N3 Stage
Time frame: After 6 weeks of CPAP (Treatment)
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.
Polysomnography - Minutes of REM Stage
Time frame: After 6 weeks of CPAP (Treatment)
Polysomnography - Sleep Efficiency
Time frame: After 6 weeks of CPAP (Treatment)
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).
3 secondary outcomes
IVGTT (Intravenous Tolerance Test) - Sensitivity Index (SI)
Time frame: After treatment (6 weeks)
IVGTT (Intravenous Tolerance Test) - Acute Insulin Response
Time frame: After treatment (6 weeks)
IVGTT (Intravenous Tolerance Test) - Disposition Index (DI)
Time frame: After treatment (6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18172212Tasali 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.
- Background: PubMed 16219719Tasali 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.
- Background: PubMed 18252916Tasali 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.
- Background: PubMed 17442599Knutson 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.
- Background: PubMed 17308390Van 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.
- Background: PubMed 16983057Knutson 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.
- Background: PubMed 16408410Latta 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.
- University of Chicago Sleep Disorders CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eve Van Cauter, Ph.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Obstructive Sleep Apnea (OSA), run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polysomnography - Apnea-hypopnea Index (AHI) (time frame: After 6 weeks of CPAP (Treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00706511, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.