NCT03092921已完成不适用
The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Fisher and Paykel Healthcare2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年3月27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
- 18
- 试验地点
- 2
- 主要终点
- Acceptability
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 seal/mask.
详细描述
A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week.
An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 oro-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 Mask Seal
Experimental
Participants to use trial seal in-home for 1 week
干预措施: F&P Mask Seal (Device)
F&P Mask
Experimental
Participants to use trial mask in-home for 2 weeks
干预措施: F&P Mask (Device)
结局指标
主要结局
Acceptability
时间窗: 2 weeks in home
Subjective questionnaire
Ease of use
时间窗: 2 weeks in home
Subjective questionnaire
次要结局
- Objective leak data(1 week in home)
研究者
研究点 (2)
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