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| Name | Class |
|---|---|
| China Medical University, China | OTHER |
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This purpose of this study is to
Obstructive sleep apnea (OSA), characterized with chronic intermittent hypoxia (CIH) and sleep fragmentation, is associated with three-fold higher risk of cardiovascular events. CIH could promote production of ROS which induced the adhesion of circulating monocytes, endothelium injury, and production of pro-inflammatory mediators and adhesion molecules and lead to formation of atherosclerotic plaque. Recent studies showed vascular endothelium function could be noninvasively assessed with Flow-mediated dilation (FMD) in brachial artery, whereas OSA patients have lower FMD compared to control subjects. However, the CPAP effects on vascular function have conflicting results. Conflicts usually involve the small sample size, lack of appropriate control, and inadequate control of confounding factors, like physical activity, and duration of CPAP treatment. Also, CPAP effect on other monocytes activation and inflammatory mediators are clear as well. Our previous studies showed 12-week CPAP treatment could not modify the levels of TNF-α and hsCRP. However, the 12-week treatment may be not long enough to draw the conclusions for benefit from long-term CPAP therapy. Therefore, we plan to conduct a cross-sectional followed by a double blind, randomized, placebo-control, parallel-group interventional study to prove our hypothesis that OSA can lead to endothelial dysfunction, monocytes activation, and pro-inflammatory state which leads to and vasculopathy and those changes can be reverted by CPAP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy non-OSA control | No Intervention | ||
| OSA receiving therapeutic CPAP | Experimental |
| |
| OSA receiving subtherapeutic CPAP | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic CPAP | Device | CPAP ventilator, optimal pressure decided by CPAP manual titration, daily use at sleep, six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| vascular reactivity of brachial artery and pulse wave velocity | six months |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of adhesion molecule expression on monocytes | six months | |
| levels of extra and intracellular cytokine | six months |
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OSA patients
Inclusion Criteria:
Exclusion Criteria:
Control subjects
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peilin Lee, M.D. | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
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| Subtherapeutic CPAP | Device | Subtherapeutic CPAP ventilator, pressure <3 cmH2O, daily use at sleep, six months |
|
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007249 | Inflammation |
| D002318 | Cardiovascular Diseases |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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