The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal: a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 3
- 主要终点
- Sleep apnoea severity, daytime symptoms of sleep apnoea
研究概览
简要总结
Randomised, placebo-controlled trial of continuous positive airway pressure therapy (CPAP) versus Provent® and Placebo-Provent® to define the effects of Provent® on the severity of obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk.
详细描述
Randomised, placebo-controlled trial of Provent® versus Placebo-Provent® versus continuous positive airway pressure therapy (CPAP) to define the effects of Provent® on the severity of obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk in patients with obstructive sleep apnea.
Patients successfully treated with CPAP will be randomised to one of three arms for a duration of 2 weeks:
- Withdraw CPAP and use Provent®
- Withdraw CPAP and use Placebo-Provent®
- Continue treatment with CPAP
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 obstructive sleep apnoea (at the time of original diagnosis) with an oxygen desaturation index (ODI, >4% dips) of between 10 and 50/h and an ESS of >10 (these thresholds will exclude subjects with borderline and very severe forms of OSA in whom there may be a disproportionate treatment effect).
- •Currently >10/h oxygen desaturations (>4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP.
- •Treated with NCPAP for more than 12 months, minimum compliance 4h per night.
- •Current ESS <
- •Written informed consent.
排除标准
- •Previous ventilatory failure (awake resting arterial oxygen saturation <93% or arterial PCO2 > 6kPa).
- •Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (>180/110mmHg).
- •Previously diagnosed with Cheyne-Stokes breathing.
- •Current professional driver.
- •Any sleep related accident.
- •Age <20 or >75 years at trial entry.
- •History of chronic nasal obstruction.
- •Mental or physical disability precluding informed consent or compliance with the protocol .
- •Non-feasible trial follow-up (for example, distance from follow-up centre, physical inability).
研究组 & 干预措施
CPAP
干预措施: CPAP (Procedure)
Provent
干预措施: Provent® (Device)
Placebo-Provent
干预措施: Provent® (Device)
Placebo-Provent
干预措施: Placebo-Provent® (Device)
CPAP
干预措施: Provent® (Device)
结局指标
主要结局
Sleep apnoea severity, daytime symptoms of sleep apnoea
时间窗: 2 weeks
次要结局
- Blood pressure(2 weeks)