CPAP In-home Assessment NZ
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Apnea Hypopnea Index (AHI), measured as number of events/hour hour.
研究概览
简要总结
Phase 1: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.
Phase 2: To evaluate the CPAP device with communication functionality with data upload.
详细描述
Phase 1: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.
Phase 2: 10 participants from Phase 1 will be recruited to use the device for up to 6 month in-home. Participants will attend 3 study visits at day 0, 7 30. The trial may be extended to 60 days if longer term data is required.
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
- •Aged 18 and over
- •Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
- •Be fluent in spoken and written English
排除标准
- •Contraindicated for Positive Airway Pressure (CPAP or AutoCPAP) therapy
- •Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)
- •Persons with obesity hypoventilation syndrome or congestive heart failure
- •Persons that require supplemental oxygen with their Positive Airway Pressure (CPAP or AutoCPAP) device.
- •Persons with implanted electronic medical devices (e.g cardiac pacemakers)
- •Persons who are pregnant or think they may be pregnant.
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
Apnea Hypopnea Index (AHI), measured as number of events/hour hour.
时间窗: 6 months
Obtained from the device - Phase 1 and Phase 2 of the trial
Machine reported faults, measured as number of machine faults
时间窗: 6 months
Obtained from the device - Phase 1 and Phase 2 of the trial
Log of safety-related events, measured as number of safety-related faults
时间窗: 6 months
Obtained from the device - Phase 1 and Phase 2 of the trial
Participant reported faults, measured as number of participant complaints
时间窗: 6 months
Obtained from the follow up visits - Phase 1 and Phase 2 of the trial
次要结局
- Perception of the device, measured through questionnaire(6 months)