NCT04938128撤回不适用
The Effect of CPAP on Nocturnal Dipping in Normotensive Patients With Moderate-severe Obstructive Sleep Apnoea, a Multicentre Randomised Controlled Trial
St Vincent's University Hospital, Ireland1 个研究点 分布在 1 个国家开始时间: 2021年4月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in Dipping status
研究概览
简要总结
This is an open-label, parallel, prospective, randomised control trial evaluating the effect of Continuous Positive airway pressure (CPAP), the standard treatment for obstructive sleep apnea (OSA) versus control (diet and lifestyle advice) on dipping status and blood pressure parameters in 100 non-dipper normotensive patients with moderate to severe obstructive sleep apnea and without established cardiovascular or metabolic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed moderate-severe OSA (by standard criteria)
- •Absence of known hypertension and antihypertensive medication
- •Office blood pressure <140/90mmHg
- •Age 18 - 70 years
- •Able to provide written, informed consent
排除标准
- •Pregnancy
- •Previous diagnosis of OSA or previous CPAP treatment
- •Diagnosis of Diabetes Mellitus
- •Active treatment for malignancy or severe psychiatric disorder
- •History of cardiovascular disease or cerebrovascular disease
- •Moderate or severe chronic kidney disease (CKD) defined as a eGFR of ≤ 44mL/min/1.73m2
- •Dipper on ABPM
- •Morbid obesity, defined as BMI ≥40
- •Professional drivers or drivers with a history of road-traffic accident due to sleepiness
- •Severe excessive daytime sleepiness defined as Epworth sleepiness scale (ESS) >15
结局指标
主要结局
Change in Dipping status
时间窗: 3 months
Change in % dipping after 3 months of treatment with CPAP versus Control
次要结局
- Change in blood pressure parameters(3 months)
- Change in the mean 24-hour ambulatory blood pressure (BP)(3 months)
研究者
Dr Silke Ryan
Clinical Professor, Consultant in Respiratory and Sleep Medicine
St Vincent's University Hospital, Ireland
研究点 (1)
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