NCT01797653已完成不适用
The Effects of CPAP-withdrawal on Microvascular Function in Patients With Obstructive Sleep Apnea: A Randomized-controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- hyperaemic myocardial blood flow
研究概览
简要总结
Randomized controlled trial (therapeutic vs. placebo CPAP) including 46 patients with obstructive sleep apnea (OSA) to define the physiological effects of continuous positive airway pressure (CPAP) therapy withdrawal on myocardial perfusion and dermal and renal microvascular function during a 2 week period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Objectively confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI, =4% dips) of >20/h and an ESS of >
- •Currently >20/h oxygen desaturations (=4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP.
- •Treated with CPAP for more than 12 months, minimum compliance 4h per night, AHI<10 with treatment (according to CPAP machine download data).
- •Current ESS <10.
排除标准
- •Previous ventilatory failure (awake SpO2 <93% and PaCO2>6kPa).
- •Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg)
- •Previously diagnosed with Cheyne-Stokes breathing.
- •Current professional driver; Any previous sleep related accident.
- •Age <20 or >75 years at trial entry.
- •Acute inflammatory disease
研究组 & 干预措施
Placebo CPAP
Placebo Comparator
patients established on CPAP therapy, who are randomized to the placebo comparator, will use a CPAP device with subtherapeutic pressure during two weeks.
干预措施: CPAP therapy withdrawal (Other)
therapeutic CPAP
Active Comparator
patients who are randomized to the active comparator, will continue with CPAP treatment with therapeutic pressure during two weeks
干预措施: Continue CPAP treatment (Procedure)
结局指标
主要结局
hyperaemic myocardial blood flow
时间窗: 2 weeks
次要结局
- Coronary flow reserve(2 weeks)
- Urine albumine excretion rate(2 weeks)
- Dermal microvascular vasodilatory response(2 weeks)
研究者
研究点 (1)
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