Field Usability Study of Eclipse CPAP Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bleep, LLC
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Number of Participants Who Asked for Additional Information
研究概览
简要总结
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device will be randomized.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device.
排除标准
- •Diagnosis of any medical or behavioral conditions that would compromise subject safety.
- •Under the age of 18: target for this current version of the platform is the adult population.
结局指标
主要结局
Number of Participants Who Asked for Additional Information
时间窗: Throughout the duration of the study (48 hours)
The total count of participants who asked for additional information during the course of home use of the mask was recorded
Mask Likeability
时间窗: At 48 hours
A 16-item patient survey was administered to the participants at the end of the study. Patients had to answer according to a Likert scale (1: worst, 5:best). Here, this reflects the average of all the answered items. For example, question number one had an average score of 4.52, question number 2 had an average score of 4.21, etc. Since all questions reflect mask likability, they were averaged to provide an overall score.
Number of Participants Who Experienced Technical Issues
时间窗: The duration of the trial (48 h)
Total count of participants who reported technical issues during the course of the 48 h home use of the mask were recorded
次要结局
未报告次要终点