Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

Not Applicable

Completed

• Conditions: Lung Disease
• Interventions: Device: Continuous Dose; Device: Pulse Dose (Sleep Mode)

• 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.

Study Timeline

• Study First Submitted: 2012-08-24
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-06
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2016-10-07
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-19
• Last Update Submitted: 2018-10-19
• Results First Posted: 2018-11-16
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Continuous dose	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.
Pulse dose ('sleep mode')	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

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

Trial Locations

Locations (1)

Sukhdev Grover and Associates; 🇺🇸 Monroeville, Pennsylvania, United States