Trial Outcomes & Findings for Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator (NCT NCT01679301)
NCT ID: NCT01679301
Last Updated: 2018-11-16
Results Overview
A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Day 1
Results posted on
2018-11-16
Participant Flow
Participant milestones
| Measure |
Participants
All Participants enrolled in the study
|
Continuous Dose Then 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.
Continuous Dose: SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
|
Pulse Dose ('Sleep Mode') Then 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): SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
|
|---|---|---|---|
|
Screening Period
STARTED
|
11
|
0
|
0
|
|
Screening Period
COMPLETED
|
8
|
0
|
0
|
|
Screening Period
NOT COMPLETED
|
3
|
0
|
0
|
|
Study Period
STARTED
|
0
|
4
|
4
|
|
Study Period
COMPLETED
|
0
|
4
|
4
|
|
Study Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Participants
All Participants enrolled in the study
|
Continuous Dose Then 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.
Continuous Dose: SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
|
Pulse Dose ('Sleep Mode') Then 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): SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
|
|---|---|---|---|
|
Screening Period
screen failure
|
3
|
0
|
0
|
Baseline Characteristics
Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
Baseline characteristics by cohort
| Measure |
Participants
n=11 Participants
All Participants enrolled in the study
|
|---|---|
|
Age, Continuous
|
67.76 years
STANDARD_DEVIATION 8.76 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
|
Body Mass Index
|
30.25 kg/m^2
STANDARD_DEVIATION 9.8 • n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping
Outcome measures
| Measure |
Continuous Dose
n=8 Participants
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.
Continuous Dose: SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
|
Pulse Dose ('Sleep Mode')
n=8 Participants
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): SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
|
|---|---|---|
|
Oxygen Saturation Values Obtained From Pulse Oximetry
Oxygen Saturation (SpO2) while Awake
|
97.6 percentage of oxygen saturation (SpO2)
Standard Deviation 1.14
|
95.8 percentage of oxygen saturation (SpO2)
Standard Deviation 1.92
|
|
Oxygen Saturation Values Obtained From Pulse Oximetry
SpO2 while in non rapid eye movement sleep (NREM)
|
97 percentage of oxygen saturation (SpO2)
Standard Deviation 2.45
|
96 percentage of oxygen saturation (SpO2)
Standard Deviation 2.1
|
|
Oxygen Saturation Values Obtained From Pulse Oximetry
SpO2 while in rapid eye movement sleep (REM)
|
100 percentage of oxygen saturation (SpO2)
Standard Deviation 0
|
97.5 percentage of oxygen saturation (SpO2)
Standard Deviation 2.38
|
|
Oxygen Saturation Values Obtained From Pulse Oximetry
SpO2 over while in bed (TIB (time in bed))
|
97 percentage of oxygen saturation (SpO2)
Standard Deviation 2.45
|
96.2 percentage of oxygen saturation (SpO2)
Standard Deviation 2.23
|
Adverse Events
Continuous Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pulse Dose ('Sleep Mode')
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place