NCT00262366已完成不适用
Titration Efficacy of Automatic CPAP Versus Fixed CPAP, Following a Prediction Formula in Patients With OSAS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring
研究概览
简要总结
Comparison of automatic CPAP with fixed CPAP in patients with OSAS
详细描述
The polysomnography is divided into two parts, randomly assigned:
- in one part, the patient uses the automatic CPAP device in titration mode
- in the other part, the patient uses the CPAP device, in fixed mode according to the prediction formula
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
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
- •Patients with proven Obstructive Sleep Apnea Syndrome
- •Apnea-hypopnea-index > 20/h
- •Awaking index > 30/h
排除标准
- •Severe nasal obstruction
- •Hypoventilation
- •Excessive sleep fragmentation caused by non-respiratory factors
- •COPD (FEV1/FVC < 65%)
- •CPAP compliance < 3h per night
- •Insufficient sleep time (< 2h TST) during one of both parts of the split night CPAP-titration
- •Patients needing > 16 mbar CPAP pressures
结局指标
主要结局
Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring
Arousal index
Pressure profile Auto-CPAP (P50, P95 en Pmax)
All outcomes are measured during polysomnography
次要结局
- Pressure adaptation during polysomnography according to body position and sleep stage, pressure variability
- Measurements of comfort, subjective evaluation by the patient by questionnaires immediately after polysomnography
研究者
研究点 (2)
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