Post Market Clinical Follow Up of ResMed Mask Systems
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ResMed
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- CPAP Pressure (cmH2O)
研究概览
简要总结
Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .
详细描述
This is an open label, prospective, multi-centre, single arm study for post market clinical follow up. The study will be conducted in the home environment remotely. Eligible participants currently using older generations of CPAP masks will use the new generation ResMed mask system in the same mask category to their own (nasal, full face, pillow) in place of their own mask for 90 nights and complete a series of questionnaires at specified study checkpoints.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants willing to give written informed consent
- •Participants who can read and comprehend English
- •Participants who ≥ 18 years of age
- •Participants being treated for OSA for ≥ 6 months
- •Participants currently using a suitable mask system
- •Participants currently using CPAP device compatible with AirView, or with download capacity from CPAP machine from data cards
排除标准
- •Participants using Bilevel flow generators
- •Participants who are or may be pregnant
- •Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
- •Participants believed to be unsuitable for inclusion by the researcher
- •Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only)
结局指标
主要结局
CPAP Pressure (cmH2O)
时间窗: up to 90 days
Calculated average pressure from the CPAP machine which indicates how much pressure patients required to keep their airway open
Leak (L/minute)
时间窗: up to 90 days
Calculated leak from CPAP machine which assess how well mask seals on patients
Apnea Hypopnea Index (event/hour)
时间窗: up to 90 days
Apnea Hypopnea events per hour taken from the participant's CPAP device used during the study
Adverse Events
时间窗: up to 90 days
Device related adverse events during the study period will also be assessed.
Usage Hours (hours/night)
时间窗: up to 90 days
Average usage hours taken from the participant's CPAP device used during the study
次要结局
- General Usability(up to 90 days)