Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Oxygen Saturation Values Obtained From Pulse Oximetry
研究概览
简要总结
The SimplyGo Study is a single site, cross-over study which aims to enroll a maximum of 30 participants (to allow for 20 completed data sets) with a prescription for nocturnal oxygen, and meeting all eligibility criteria.
详细描述
All participants will undergo a single night polysomnography testing in a sleep lab while they're oxygen saturation (SpO2) is monitored. The study has a cross-over design, in which participants will receive their oxygen prescription in two different modes at different times during the night. The assignment (sleep vs. continuous mode) to which participants will initiate the night will be randomized, and all participants will utilize each of the two modes during the study. The hypothesis of this study is that there will not be a significant difference in SpO2 for participants while they use the SimplyGo Portable Oxygen Concentrator, set in 'Sleep Mode', or pulsed oxygen flow, as compared to their SpO2 while on continuous flow oxygen during sleep during the course of the one night sleep study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Continuous dose
Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator.
干预措施: Continuous Dose (Device)
Pulse dose ('sleep mode')
Users will be randomized to either receive oxygen via continuous dose oxygen or pulsed dose ('sleep' mode) for the first part of the night and will switch for the second part of the night using the SimplyGo Portable Oxygen Concentrator
干预措施: Pulse Dose (Sleep Mode) (Device)
结局指标
主要结局
Oxygen Saturation Values Obtained From Pulse Oximetry
时间窗: Day 1
A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping
次要结局
未报告次要终点