ISRCTN31885415已完成未知
The impact of changing the pressure generating device in people with sleep apnoea using Continuous Positive Airway Pressure (CPAP) less than 4 hours per night: a randomised controlled crossover trial
Papworth Hospital NHS Foundation Trust (UK)0 个研究点目标入组 40 人开始时间: 2010年3月18日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Diagnosed OSA (AHI greater than 4 per hour)
- •2. On CPAP for at least 6 weeks with average use less than 4 hours per night
- •3. Intolerant of CPAP despite ensuring pressure minimised to least effective, mask fit and humidification reviewed as appropriate
排除标准
- •1. Refuse informed consent or unable to give consent.
- •2. AHI less than 5 per hour off CPAP.
- •3. Moderate to severe airflow obstruction (Forced Expiratory Volume in 1 second [FEV1] / Forced Vital Capacity Percentage [FVC%] less than 60%).
- •4. Central sleep apnoea (central events more than 50% of all the apnoeas / hypopnoeas).
- •5. Decompensated congestive heart failure on clinical examination.
- •6. Hypercapnia (PaCO2 >6.5 KPa).
- •7. Previous exposure to Bi-level positive airway pressure support.
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