NCT04063436撤回不适用
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
Fisher and Paykel Healthcare2 个研究点 分布在 1 个国家开始时间: 2019年9月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Performance of new nasal pillows mask
研究概览
简要总结
This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are ≥22 years of age
- •Weigh ≥66 lbs
- •Have been formally diagnosed with OSA by a physician
- •Have an AHI ≥5 on a diagnostic night
- •Have been prescribed PAP therapy to treat OSA by a physician
- •Are an existing nasal pillows mask user
- •Have been using a nasal pillows mask for ≥3 months prior to enrolment into the study
- •Are compliant with PAP therapy for ≥4 hours per night for 70% of nights
- •Are fluent in spoken and written English
- •Possess the capacity to provide informed consent
排除标准
- •Are intolerant to PAP therapy
- •Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
- •Are currently diagnosed with respiratory disease or CO2 retention
- •Are pregnant or think they may be pregnant
- •Have an IPAP pressure of >25 cmH2O
- •Persons who use a PAP therapy machine for the delivery of medicines, except O2
- •Use a PAP therapy machine that does not possess data recording capabilities to capture AHI and leak information that is accessible to OSMI
结局指标
主要结局
Performance of new nasal pillows mask
时间窗: 14±5 days
The new nasal pillows mask provides adequate PAP therapy for OSA when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines.
次要结局
- Comfort of new nasal pillows mask(14±5 days)
- Usability of new nasal pillows mask(14±5 days)
研究者
研究点 (2)
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