The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Trial Mask usability
研究概览
简要总结
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.
详细描述
A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Adult (18+ years of age)
- •Able to give written consent
- •AHI ≥ 5 on diagnostic night
- •Either prescribed APAP, CPAP or Bi-level PAP for OSA
排除标准
- •Inability to give written consent
- •Anatomical or physiological conditions making PAP therapy inappropriate
- •Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
- •Current diagnosis of respiratory disease or CO2 retention
- •Pregnant or may think they are pregnant.
结局指标
主要结局
Trial Mask usability
时间窗: 14 ± 4 days in home
Questionnaire on ease-of-use (very easy to very difficult) Subjective
Trial mask Performance
时间窗: 14 ± 4 days in home
Questionnaire on performance (very good to very poor)- Subjective
次要结局
- Trial mask Reliability(5 months and 2 weeks in home)
- Trial mask performance measured in L/min(14 ± 4 days in home)