Reassure Respiration Rate Device: Home User Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 48
- 主要终点
- Percentage of Nights' Data That Were Successfully Recorded
研究概览
简要总结
This is a usability evaluation of the Reassure device. The device is a non-contact device which passively monitors breathing.
The purpose of this usability evaluation is to understand any issues that the intended user population have while using the device unsupervised in the home and to determine if the device can collect data that is of sufficient quality to be successfully analysed for respiration rate.
详细描述
The aim of the set of Reassure Home User Trials is to understand any usability issues that users have while using the Reassure non contact monitor in their home environment.
Other objectives:
- To gather useful feedback on the user interface and suggestions for its improvement.
- To gather information on the device stability in the more variable conditions of the home user environment.
- To gather data in order to demonstrate compliance with IEC62366, and thus IEC60601-1
The users had the device for a minimum of 10 nights, to confirm if the device could be used for an extended period and the likely compliance rates of users
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •volunteer, no previous exposure to the device
排除标准
- •restless leg syndrome or other conditions giving to uncontrolled movements whilst asleep
结局指标
主要结局
Percentage of Nights' Data That Were Successfully Recorded
时间窗: At least 10 nights
The definitions utilised to determine the patient's success or otherwise at making a recording of their sleep respiration data are: • That 67% of the duration of the recording has to be of sufficient quality for the respiration rate algorithms to be able to discern a respiration rate. AND • The duration of analysable data is to be at least 2 hours.
次要结局
- Percentage of Recordings With Successful First Time Transmission(For at least 10 nights of recordings)