CPAP In-home Assessment Australia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Apnea Hypopnea Index (AHI), measured as number of events/hour
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
- 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 OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy.
排除标准
- •Persons contraindicated for Continuous Positive Airway Pressure (CPAP) 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 CPAP device.
- •Persons with implanted electronic medical devices (e.g. cardiac pacemakers).
- •Persons who are pregnant or think they might be pregnant.
- •Persons whose primary language is other than English.
- •Persons in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process.
- •Persons highly dependent on medical care.
- •People with cognitive impairment, an intellectual disability or a mental illness
结局指标
主要结局
Apnea Hypopnea Index (AHI), measured as number of events/hour
时间窗: 6 months
Obtained from the device
Log of safety-related events, measured as number of safety-related faults
时间窗: 6 months
Obtained from the device
Machine reported faults, measured as number of machine faults
时间窗: 6 months
Obtained from the device
Participant reported faults, measured as number of participant complaints
时间窗: 6 months
Obtained from the follow up visits
次要结局
- Perception of the device, measured through questionnaire(6 months)