CPAP In-home Assessment USA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 8
- 主要终点
- Machine Reported Faults, Measured as Number of Patients With Machine Faults
研究概览
简要总结
The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
详细描述
Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.
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
- •Aged 22 and over
- •Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
- •For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.
排除标准
- •Contraindicated for PAP (CPAP or AutoCPAP) therapy
- •Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
- •Has obesity hypoventilation syndrome or congestive heart failure
- •Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
- •Has implanted electronic medical devices (e.g cardiac pacemakers)
- •Pregnant or think they may be pregnant
- •Not fluent in spoken and written English.
研究组 & 干预措施
Investigational CPAP device
Fisher & Paykel Healthcare CPAP Device
干预措施: Fisher & Paykel Healthcare CPAP Device (Device)
结局指标
主要结局
Machine Reported Faults, Measured as Number of Patients With Machine Faults
时间窗: 6 months
Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults
时间窗: 6 months
Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.
时间窗: 6 months
Participant Reported Faults, Measured as Number of Participant Complaints
时间窗: 6 months
次要结局
- How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device(6 months)