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Obstructive sleep apnea is a condition in which people have decreased breathing during their sleep. Untreated sleep apnea has been linked to increased risk for cardiovascular diseases.
This research study is looking at blood clotting factors and blood vessel function in health volunteers and patients with newly diagnosed or untreated obstructive sleep apnea to better understand the underlying mechanisms for increased cardiovascular risk.
Cardiovascular disease (CVD), which includes strokes, has been the number one killer in the United States.Each year about 700,000 people experience a new or recurrent stroke, which translates into about one stroke every 45 seconds. Apart from traditional risk factors for stroke such as hypertension, smoking and atrial fibrillation, obstructive sleep apnea is now being increasingly recognized as another important treatable risk factor.
The majority of strokes and myocardial infarctions are due to atherothrombotic events. Impaired fibrinolytic activity increases the propensity for thromboembolic events. Many different candidate molecules have been studied as the cause of a hypercoagulable state. Plasminogen Activator Inhibitor-1 (PAI-1) is the major physiologic inhibitor of the body's fibrinolytic system including the principal serine protease tissue-type plasminogen activator (t-PA). It is therefore poised to be a pivotal regulator of the fibrinolytic system.Recent studies have shown that PAI-1 levels are elevated in patients with obstructive sleep apnea (OSA) and that PAI-1 levels correlate with severity of OSA.
The purpose of this pilot study is twofold:
Data gathered from this pilot study will be used to initiate a more comprehensive prospective study exploring the link between OSA, endothelial function, the fibrinolytic system and cardiovascular events. This area can be further explored by prospectively following patients to assess for a reduction in such events with treatment of OSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy controls | 18 years or older with body mass index between 25-45 | ||
| Obstructive Sleep Apnea Group | Age 18 years or older with body mass index between 25 and 45 |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Levels of Mean PAI-1 Activity in Patients With Obstructive Sleep Apnea and Controls. | at the initial visit |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Endothelial (Blood Vessel) Wall Diameter in Patients With Obstructive Sleep Apnea Versus Controls. | at initial visit |
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Inclusion Criteria:
Exclusion Criteria:
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We are looking for adults over age 18 years without significnt medical or psychiatric conditions (other than sleep apnea).
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| Name | Affiliation | Role |
|---|---|---|
| Kanika Bagai, M.D | Vanderbilt University Medical Center, Nashville, TN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center,Department of Neurology | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16282178 | Background | Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104. |
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Once patients were enrolled in the trial and assigned to the groups, we were able to complete the protocols without having to exclude any participants.
Participants were recruited from the Vanderbilt sleep disorders clinics and from the community using emails and flyers from study start date in 2008- 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Controls | 18 years or older with body mass index between 25-45 |
| FG001 | Obstructive Sleep Apnea Group | Age 18 years or older with body mass index between 25 and 45 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Controls | 18 years or older with body mass index between 25-45 |
| BG001 | Obstructive Sleep Apnea Group | Age 18 years or older with body mass index between 25 and 45 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Comparison of Levels of Mean PAI-1 Activity in Patients With Obstructive Sleep Apnea and Controls. | Posted | Mean | Standard Error | IU/ml | at the initial visit |
|
|
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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 | Healthy Controls | 18 years or older with body mass index between 25-45 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kanika Bagai, MD, Assistant Professor | Vanderbilt Universit | 6153220283 | kanika.bagai@vanderbilt.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Blood samples to measure plasminogen activator inhibitor-1 (PAI-1) and tissue plasminogen activator (t-PA)levels, endothelial function,fasting lipid profile and glucose levels.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Comparison of Endothelial (Blood Vessel) Wall Diameter in Patients With Obstructive Sleep Apnea Versus Controls. | Posted | Mean | Standard Deviation | mm | at initial visit |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Obstructive Sleep Apnea Group | Age 18 years or older with body mass index between 25 and 45 | 0 | 17 | 0 | 17 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |