Effect of Continuous Positive Airway Pressure (CPAP) on Cardiovascular Biomarkers in Patients With Obstructive Sleep Apnea.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effect of CPAP therapy on blood pressure
研究概览
简要总结
CPAP, the standard treatment for Obstructive sleep apnea syndrome (OSAS) that reduces sleep fragmentations and neurocognitive deficit in OSAS may also have a key role in reduction of cardiovascular, mortality risks in the same patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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)
结局指标
主要结局
Effect of CPAP therapy on blood pressure
时间窗: 7 months
Effect of CPAP therapy on insulin resistance
时间窗: 7months
Effect of CPAP therapy on plasma hs-CRP
时间窗: 7months
Effect of CPAP therapy on lipid profile
时间窗: 7months
Effect of CPAP therapy on urinary albumin-creatinine ratio
时间窗: 7months
次要结局
- Effect of CPAP on adipokines and oxidative stress markers(3months)
- Effect of CPAP on inflammatory cytokine levels.(3months)
- Effect of CPAP on visceral fat and other imagings(3months)
- Effect of CPAP on carotid intima medical thickness(3months)
- Effect of CPAP on anthropometric parameters(3 months)
研究者
S.K.SHARMA
Professor and Haed
All India Institute of Medical Sciences, New Delhi