Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 80
Updated:11/18/2018
Start Date:September 2012
End Date:July 2014

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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.

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.

Inclusion Criteria

1. Males and Females, ages 21-80

2. Current prescription for supplemental oxygen at night; Can be pulsed dose or
continuous

3. Willing and able to provide informed consent

Exclusion Criteria

1. Medically unstable participants per discretion of the principal investigator

2. Diagnosis of sleep apnea, per chart review, self report or rated high risk based on
the Berlin Questionnaire

3. Participants unable or unwilling to spend one night in a sleep lab

4. Nocturnal oxygen requirements > 5 liters per minute

5. Currently employed by a manufacturer of respiratory products or family member employed
by a manufacturer of respiratory products

6. Employee or family member that is affiliated with Philips
We found this trial at
1
site
Monroeville, Pennsylvania 15146
Principal Investigator: Sukhdev Grover, MD
Phone: 412-856-5778
?
mi
from
Monroeville, PA
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