Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
Primary Purpose
Lung Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulse Dose (Sleep Mode)
Continuous Dose
Sponsored by
About this trial
This is an interventional other trial for Lung Disease focused on measuring oxygen
Eligibility Criteria
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
Sites / Locations
- Sukhdev Grover and Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Continuous dose
Pulse dose ('sleep mode')
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01679301
Brief Title
Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
Official Title
Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease
Keywords
oxygen
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous dose
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pulse dose ('sleep mode')
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Pulse Dose (Sleep Mode)
Intervention Description
SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
Intervention Type
Device
Intervention Name(s)
Continuous Dose
Intervention Description
SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
Primary Outcome Measure Information:
Title
Oxygen Saturation Values Obtained From Pulse Oximetry
Description
A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sukhdev Grover, MD
Organizational Affiliation
Medical Director, Sukhdev Grover and Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sukhdev Grover and Associates
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
We'll reach out to this number within 24 hrs