Effect of CPAP on Biomarkers in Patients With OSA (CPAP)
Effect of Continuous Positive Airway Pressure (CPAP) on Cardiovascular Biomarkers in Patients With Obstructive Sleep Apnea.
研究概览
地位
条件
详细说明
Obstructive sleep apnea (OSA) is a condition in which there is collapse of the upper airway during sleep, as a result of which there is a decrease or complete cessation of airflow. This leads to repeated episodes of hypoxia during sleep and sleep fragmentation. It is a highly prevalent though under-recognized clinical problem.There is increasing evidence that inflammation plays important role in development of cardiovascular complications in patients with OSA.
Continuous positive airway pressure (CPAP) is the standard treatment for OSA with significant symptoms.However, it is a costly treatment option and poor compliance is an important limiting factor. CPAP treatment has been shown to improve the daytime somnolence and neurocognitive function in people with OSAS. However, its effect on cardiovascular biomarkers in people with OSAS has not been satisfactorily assessed.
This study aims to assess the effect of CPAP treatment on cardiovascular biomarkers in OSA.
研究类型
注册 (预期的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Delhi
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New Delhi、Delhi、印度、110029
- 招聘中
- All India Institute of Medical Sciences
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副研究员：
- Manish Soneja, MD
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接触：
- Surendra K Sharma, MD, Ph.D
- 电话号码：91-11-26594415
- 邮箱：sksharma@aiims.ac.in
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首席研究员：
- Surender K Sharma, MD, Ph.D
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副研究员：
- M Irshad, MD
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副研究员：
- Vishubhatla Sreenivas, Ph.D
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副研究员：
- Ramakrishnan Lakshmy, Ph.D
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副研究员：
- Atin Kumar, MD
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副研究员：
- Priya Jagia, MD
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副研究员：
- Deepak Damodaran, M.B.B.S.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
The 1st part of the study will include
- males and females, aged 30-65 years,
- with AHI >5 and excessive daytime sleepiness
- naïve to CPAP treatment.
- Subjects from first part of the study who have moderately severe OSAS and have never received treatment for OSA,diabetes mellitus and hypertension
Exclusion Criteria:
- Hypothyroidism
- Chronic renal failure
- Chronic liver disease
- Chronic lung disease
- Known systemic inflammatory diseases (lupus , sarcoidosis and other connective tissue disorders),
- Use of drugs that influence urinary protein excretion (eg. steroids, lithium, NSAIDS, ACE inhibitors/Angiotensin Receptor Blockers etc.)
- Immune deficiency conditions
- Pregnancy
- Active menstruation at time of sampling
- Macroalbuminuria (aACR>300mg/g),
- Patients of coronary artery disease and left ventricular dysfunction
- Not on treatment for hypertension, diabetes mellitus or dyslipidemia
- Long lasting hypertension or diabetes mellitus (more than 5 years after diagnosis)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：1
Device: AutoSet Spirit--Wash--Modified-AutoSet Spirit 3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between
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3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between
其他名称：
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其他：2
3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between
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3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Effect of CPAP therapy on blood pressure
大体时间：7 months
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7 months
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Effect of CPAP therapy on insulin resistance
大体时间：7months
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7months
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Effect of CPAP therapy on plasma hs-CRP
大体时间：7months
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7months
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Effect of CPAP therapy on lipid profile
大体时间：7months
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7months
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Effect of CPAP therapy on urinary albumin-creatinine ratio
大体时间：7months
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7months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Effect of CPAP on anthropometric parameters
大体时间：3 months
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3 months
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Effect of CPAP on visceral fat and other imagings
大体时间：3months
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3months
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Effect of CPAP on carotid intima medical thickness
大体时间：3months
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3months
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Effect of CPAP on adipokines and oxidative stress markers
大体时间：3months
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3months
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Effect of CPAP on inflammatory cytokine levels.
大体时间：3months
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3months
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合作者和调查者
调查人员
- 首席研究员：Surendra K Sharma, MD,Ph.D、All India Institute of Medical Sciences, New Delhi
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- SKS/CPAP-OSAS/2009
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AutoSet Spirit--Wash--Modified-AutoSet Spirit的临床试验
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Centre Hospitalier Universitaire de Saint EtienneAssociation Lyonnaise de Logistique Posthospitalière终止