NCT03156413已完成不适用
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Fisher and Paykel Healthcare2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年5月29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
- 12
- 试验地点
- 2
- 主要终点
- Ease of use
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 mask.
详细描述
A maximum of 12 OSA participants who currently use a nasal mask will be recruited for the trial. Participant will be on the trial for 1 night (in-lab)
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 consent
- •Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
- •Prescribed PAP for OSA
- •Existing nasal mask user
排除标准
- •Inability to give consent
- •Patients who are in a coma or a decreased level of consciousness
- •Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
- •Commercial drivers who are investigated by New Zealand Transport Agency
- •Current diagnosis of carbon dioxide (CO2) retention
- •Pregnant or may think they are pregnant
研究组 & 干预措施
F&P Nasal Mask
Experimental
Trial nasal pillows CPAP mask
干预措施: F&P nasal mask (Device)
结局指标
主要结局
Ease of use
时间窗: 1 night
Subjective questionnaire
Acceptability
时间窗: 1 night
Subjective questionnaire
次要结局
- Objective leak data(1 night)
研究者
研究点 (2)
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