NCT02972970已完成不适用
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
Metamason2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2016年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- 1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit
研究概览
简要总结
Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched" CPAP Mask
详细描述
- Assess the process of scan, fit and print
- Subjective/objective assessment of fit of the Aveera during the 2 week use for leaks and comfort
- Ethnographic insights into the user experience of the scan, fit, print process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •≥ 18 years of age
- •Both genders
- •Currently prescribed fixed pressure CPAP or APAP for the treatment of OSA
- •Currently CPAP pillows and nasal mask users
- •Patients who are adherent as defined by conventional standards (i.e. 4 hours per night/70% of the nights)
排除标准
- •Unwilling to wear the AVEERA
- •Concern about privacy of data
- •Full face mask user
- •Any medical condition deemed by the investigator to pose an issue with the subject's participation.
- •Upper limit of CPAP pressure of ≥ to 15 cm H20 or APAP a upper limit pressure setting of ≥17cm H2O
- •Requires the use of supplemental oxygen
结局指标
主要结局
1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit
时间窗: 2 weeks
Assess the clinical utility of using a 3D scanning process, printing and fit assessment
次要结局
未报告次要终点
研究者
研究点 (2)
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