NCT00751335已完成不适用
Prospective, Randomized, Double-blind Cross-over Study Comparing ThermoSmart® to Conventional Heated Humidity in Patients Suing Continuous Positive Airway Pressure
Fisher and Paykel Healthcare2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2006年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- CPAP Compliance
研究概览
简要总结
That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Previous diagnosis of OSA permitted, but patient must be novel to CPAP and no previous surgical intervention for OSA or treatment with an oral appliance.
- •AHI ≥ 15 OR AHI ≥ 5 + ESS ≥ 10 OR ESS ≥ 10 + a medical co-morbidity
- •Patient willing to give informed consent and follow study protocol.
排除标准
- •Wake resting SpO2 < 90%
- •Patient requires BiLevel PAP or supplemental oxygen
- •The patient is medically unstable (e.g. respiratory or cardiac failure)
- •Patient unwilling to give informed consent or follow study protocol.
结局指标
主要结局
CPAP Compliance
时间窗: 1, 4 & 8 weeks
次要结局
- Subjective & Objective Sleep Parameters(1, 4 & 8 weeks)
研究者
研究点 (2)
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