CPAP Device In-lab Assessment NZ
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Log of safety-related events, measured as number of safety-related faults
研究概览
简要总结
The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements
详细描述
Existing Adult Continuous Positive Airway Pressure (CPAP) therapy users will be recruited for an overnight polysomnography (PSG) sleep study. The participants will use the investigational CPAP device and be connected to a PSG during their session. The device performance during the session will be assessed. Outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and PSG data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •18 years or older
- •Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP)
- •Fluent in spoken and written English.
排除标准
- •Be contraindicated for PAP (fixed or auto CPAP) therapy.
- •Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia).
- •Have obesity hypoventilation syndrome or congestive heart failure.
- •Require supplemental oxygen with your PAP (fixed or auto CPAP) device.
- •Have any implanted electronic medical devices (e.g. cardiac pacemakers).
- •Be pregnant or think they might be pregnant.
结局指标
主要结局
Log of safety-related events, measured as number of safety-related faults
时间窗: 4 months
Obtained from device
Apnea Hypopnea Index (AHI) (i.e. number of events/hour).
时间窗: 4 months
Obtained from device and PSG data
Machine reported faults, measured as number of machine faults
时间窗: 4 months
Obtained from device
次要结局
- Participant perception of the device, as determined by the questionnaire responses(4 months)