Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
- Conditions
- Lung Disease
- Registration Number
- NCT01679301
- Lead Sponsor
- Philips Respironics
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Oxygen Saturation Values Obtained From Pulse Oximetry Day 1 A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sukhdev Grover and Associates
🇺🇸Monroeville, Pennsylvania, United States
Sukhdev Grover and Associates🇺🇸Monroeville, Pennsylvania, United States