NCT01679301

Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Philips Respironics · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lung Disease

Interventions

Type	Name	Description
DEVICE	Pulse Dose (Sleep Mode)	SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
DEVICE	Continuous Dose	SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-09-06
• Last updated: 2018-11-16
• Results posted: 2018-11-16

Locations

1 site across 1 country: United States