Menai Mask Systems - Clinical Study 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Usability Performance Evaluation
研究概览
简要总结
The primary objective of this study is to evaluate the subjective performance of the Menai mask systems (full face, nasal, and pillows variants), compared against Comparison mask systems.
详细描述
The study will evaluate the subjective seal, comfort, stability, usability, and humidification performance of the prototype mask systems in CPAP established patients. The performance of the prototype Menai mask systems (full face, nasal, and pillows variants) will be subjectively assessed through user questionnaires based on an 11-point Likert scale, and will be compared against Comparison masks.
The prototype masks share the same parts (cushion, frame, headgear), with the difference being that the Menai masks feature a novel vent and humidification system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants willing to provide written informed consent
- •Participants who can read and comprehend written and spoken English
- •Participants who are over 18 years of age
- •Participants who have been diagnosed with OSA
- •Participants who have been established on CPAP for ≥ 6 months
- •Participants who are currently using the same mask type/variant as the interventional mask system to be evaluated
排除标准
- •Participants who are not able to provide written informed consent
- •Participants who are unable to comprehend written and spoken English
- •Participants who are pregnant
- •Participants who are unsuitable to participate in the study in the opinion of the researcher
- •Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection, lung injury)
- •Participants who cannot participate for the duration of the trial
- •Participants who are established on bi-level support therapy
- •Participants who are not currently using the same mask type/variant as the interventional mask system to be evaluated
结局指标
主要结局
Usability Performance Evaluation
时间窗: 2 weeks
Evaluation of the usability performance (seal, comfort, etc) of the Menai masks, compared to the Comparison Menai Standard masks.
次要结局
- Humidification Performance Evaluation(2 weeks)