Lung Disease
Conditions
Keywords
oxygen
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.
Interventions
DEVICEPulse Dose (Sleep Mode)
SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
DEVICEContinuous Dose
SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation Values Obtained From Pulse Oximetry | Day 1 | A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants All Participants enrolled in the study | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Screening Period | screen failure | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Participants |
|---|---|
| Age, Continuous | 67.76 years STANDARD_DEVIATION 8.76 |
| Body Mass Index | 30.25 kg/m^2 STANDARD_DEVIATION 9.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
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
Time frame: Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Continuous Dose | 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 |
| Continuous Dose | Oxygen Saturation Values Obtained From Pulse Oximetry | SpO2 while in rapid eye movement sleep (REM) | 100 percentage of oxygen saturation (SpO2) | Standard Deviation 0 |
| Continuous Dose | 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 |
| Pulse Dose ('Sleep Mode') | Oxygen Saturation Values Obtained From Pulse Oximetry | SpO2 over while in bed (TIB (time in bed)) | 96.2 percentage of oxygen saturation (SpO2) | Standard Deviation 2.23 |
| Pulse Dose ('Sleep Mode') | Oxygen Saturation Values Obtained From Pulse Oximetry | Oxygen Saturation (SpO2) while Awake | 95.8 percentage of oxygen saturation (SpO2) | Standard Deviation 1.92 |
| Pulse Dose ('Sleep Mode') | Oxygen Saturation Values Obtained From Pulse Oximetry | SpO2 while in rapid eye movement sleep (REM) | 97.5 percentage of oxygen saturation (SpO2) | Standard Deviation 2.38 |
| Pulse Dose ('Sleep Mode') | Oxygen Saturation Values Obtained From Pulse Oximetry | SpO2 while in non rapid eye movement sleep (NREM) | 96 percentage of oxygen saturation (SpO2) | Standard Deviation 2.1 |