NCT02486380终止不适用
Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)
Fisher and Paykel Healthcare1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2015年7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
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Objective Leak data
研究概览
简要总结
This investigation is to evaluate the performance, comfort and ease of use of the Toffee full face and toffee nasal mask masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.
详细描述
Up to 20 OHS patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a F&P Toffee Full face (if they are existing full face users) or F&P Toffee Nasal (if they are existing nasal users) for an overnight polysomnography.
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
- •Diagnosed with OHS by a practicing physician
- •Existing full face mask user or a nasal mask user
- •Prescribed PAP therapy (Bi-Level or CPAP)
排除标准
- •Inability to give informed consent
- •Pregnant or think they may be pregnant
- •Anatomical or physiological conditions making PAP therapy inappropriate
- •Patients requiring supplemental oxygen with their PAP device
- •Patients who are in a coma or decreased level of consciousness
- •Existing Toffee full face and Toffee nasal mask users
- •No arterial PCO2 value from their medical records
研究组 & 干预措施
Full face/Nasal masks
Experimental
Toffee Full face/Toffee nasal
干预措施: Toffee full face mask/toffee nasal mask (Device)
结局指标
主要结局
Objective Leak data
时间窗: 1 night
Obtained from the participant's device and polysomnography (PSG)
次要结局
- Comfort(1 night)
- Subjective measurement of Leak(1 night)
- Ease of use(1 night)
- Wake after Sleep Onset (WASO)(1 night)
- Sleep efficiency(1 night)
- Arousal Index (AI)(1 night)
研究者
研究点 (1)
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