Lung DiseaseNCT01679301
Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
A study testing Pulse Dose (Sleep Mode) and Continuous Dose in people with Lung Disease, run by Philips Respironics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Disease
- What is being tested?
- Pulse Dose (Sleep Mode) and Continuous Dose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sukhdev Grover and Associates
Monroeville, Pennsylvania, 15146
About this study
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.
Read the 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
- Being tested
- Pulse Dose (Sleep Mode), Continuous Dose
- Keywords
- oxygen
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Dose (Sleep Mode)Device
SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
Continuous DoseDevice
SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
| Study group | Role | What they receive |
|---|---|---|
| Continuous dose | Active comparator | 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. Receives: Device: Continuous Dose |
| Pulse dose ('sleep mode') | Experimental | 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 Receives: Device: Pulse Dose (Sleep Mode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sukhdev Grover, MD, Principal investigator, Medical Director, Sukhdev Grover and Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679301
- Sponsor's protocol ID
- HRC-1216-SimGoSleep-SS
- Status last verified
- Oct 2018
- First submitted
- 24 Aug 2012
- Last updated
- 16 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
- ClinicalTrials.gov ID
- NCT01679301
- Acronym / sponsor ID
- HRC-1216-SimGoSleep-SS
- Conditions
- Lung Disease
- Keywords
- oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Posted 16 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous dose | Active comparator | Device: Continuous DoseUsers 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') | Experimental | Device: 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 |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse Dose (Sleep Mode)SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose. | Device | Pulse dose ('sleep mode') |
| Continuous DoseSimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose. | Device | Continuous dose |
Primary outcome
Oxygen Saturation Values Obtained From Pulse Oximetry
Time frame: Day 1
A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sukhdev Grover, MD principal investigator
Medical Director, Sukhdev Grover and Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse Dose (Sleep Mode) and Continuous Dose in people with Lung Disease, run by Philips Respironics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Saturation Values Obtained From Pulse Oximetry (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.