An Investigation to Test a Prototype Nasal Mask in the Home Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Mask User Instructions Interpretation
研究概览
简要总结
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. The clinical investigation will be conducted in New Zealand and participants will interact with the user instructions in a one hour daytime visit. A minimum of 15 participants will participate in this trial.
详细描述
This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. The clinical investigation will be conducted in New Zealand and participants will interact with the user instructions in a one hour daytime visit. This investigation is designed to evaluate the interpretation by participants of the user instructions. A total number of 20 participants, diagnosed with OSA will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects (Ethics reference 18/NTA/62).
Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor (Bhavi Ogra) as soon as possible.
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
- 是
入选标准
- •OSA Mask Users
- •18+ years of age
- •Ability to give informed consent
排除标准
- •Inability to give informed consent
研究组 & 干预措施
Arm
Experimental: User Instructions of a Novel Nasal Mask Participants to interpret user instructions in a one hour daytime visit.
干预措施: User Instructions of novel nasal mask (Device)
结局指标
主要结局
Mask User Instructions Interpretation
时间窗: 3 days
Determined as interpreted by participants from open-ended questions (Open ended questionnaire, very easy - very difficult)- Subjective
次要结局
未报告次要终点