ACTRN12613001282774已完成未知
An evaluation involving an in-lab assessment of a continuous positive airway pressure (CPAP) device for the treatment of Obstructive Sleep Apnea (OSA) along with changes in pressure, humidity and therapy modes to determine whether the device provides the same therapy and comfort as its predecessor and similar released products on the market.
Hanie Yee0 个研究点目标入组 300 人开始时间: 2013年11月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Diagnosed with OSA by a practicing sleep physician
- •AHI > 5 from diagnostic night
排除标准
- •Patients with a known history ofCerebrospinal fluid leak, abnormalities of the cribriform plate, head trauma and/or pneumocephalus
- •Patients with pathologically low blood pressure, pneumothorax, a previous history of pneumothorax, or for patients who have an increased risk of pneumothorax, such as those with bullous lung disease
- •Patient with bypassed upper airway
- •Other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea)
- •Patients with obesity hypoventilation syndrome or congestive heart failure
- •Patients that require supplemental oxygen with their CPAP device
- •Patients with implanted electronic medical devices (e.g. cardiac pacemakers)
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