NCT00252252已完成1 期
Crossover Trial of VPAP (Variable Positive Airway Pressure) Ventilation Versus AutoVPAP in Neuromuscular and Chest Wall Disease: Effects on Nocturnal Hypoventilation, Sleep Quality and Tolerance
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP.
研究概览
简要总结
The aim of the study is to compare the effects of a modified form (AutoVPAP) of the VPAP non-invasive ventilator versus standard VPAP ventilation on sleep quality and breathing during sleep in stable patients with nocturnal hypoventilation due to restrictive ventilatory disorders (eg. neuromuscular disease or chest wall disorder).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years
- •Nocturnal hypoventilation (nocturnal peak transcutaneous PCO2 > 6.5 kPa when breathing spontaneously) with
- •Congenital neuromuscular disease (eg. Duchenne muscular dystrophy, congenital muscular dystrophy), acquired neuromuscular disease (eg. old polio, bilateral diaphragm paralysis) or chest wall disease (eg. idiopathic scoliosis, thoracoplasty)
- •Recruited from 1300 patients attending Royal Brompton Hospital Lind ward ventilator clinic.
- •All patients will be familiar with non-invasive ventilation use but currently using a ventilator which is not a VPAP model eg. BiPAP Harmony, Breas PV
- •Able to understand treatment and protocol
排除标准
- •Unstable respiratory failure (PaO2 < 7.5 kPa, PaCO2 > 8.0 kPa,
- •Uncontrolled heart failure or arrhythmia
- •Moderate or severe bulbar weakness.
- •Unable to understand treatment or protocol
结局指标
主要结局
Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP.
次要结局
- Compare effects on overnight heart rate variation (as a measure of autonomic stress)
- Measure of effect on daytime sleepiness
- Compare tolerance of AutoVPAP versus standard VPAP
- Measure of hours of use of device
研究者
研究点 (2)
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