NCT02323035已完成不适用
Investigative Headgear With CPAP Mask
Fisher and Paykel Healthcare2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2014年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Participants perception of the headgear on mask performance
研究概览
简要总结
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.
详细描述
Up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level PAP for the treatment of their OSA. These include current CPAP mask users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AHI≥5 from the diagnostic night
- •≥18 years of age
- •Prescribed CPAP or Bilevel therapy for OSA
- •Existing CPAP mask users
排除标准
- •Inability to give informed consent
- •Patient intolerant to PAP
- •Anatomical or physiological conditions making PAP therapy inappropriate
- •History of respiratory disease or CO2 retention.
- •Pregnant or think they may be pregnant
- •Investigated by Land Transport Safety Authority
研究组 & 干预措施
Headgear
Experimental
Investigative Headgear with CPAP Mask.
干预措施: Headgear (Device)
结局指标
主要结局
Participants perception of the headgear on mask performance
时间窗: 2-4 weeks
Assess if the headgear with mask changes the perception of the performance of the mask.
次要结局
- Number of participants that choose this Headgear over their usual.(2-4 weeks)
研究者
研究点 (2)
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