Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator

Conditions
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Lung Disease

Intervention / Treatment
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* Device: Pulse Dose (Sleep Mode)
* Device: Continuous Dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Males and Females, ages 21-80 Current prescription for supplemental oxygen at night; Can be pulsed dose or continuous Willing and able to provide informed consent Exclusion Criteria Medically unstable participants per discretion of the principal investigator Diagnosis of sleep apnea, per chart review, self report or rated high risk based on the Berlin Questionnaire Participants unable or unwilling to spend one night in a sleep lab Nocturnal oxygen requirements > 5 liters per minute Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products Employee or family member that is affiliated with Philips

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous dose<br>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. | Device: Continuous Dose<br>* SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.<br>|
| Experimental: Pulse dose ('sleep mode')<br>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 | Device: Pulse Dose (Sleep Mode)<br>* SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Saturation Values Obtained From Pulse Oximetry | A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxygen