Trial Outcomes & Findings for AVAPS-AE Efficacy Study (NCT NCT01368614)
NCT ID: NCT01368614
Last Updated: 2019-04-26
Results Overview
Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.
COMPLETED
NA
90 participants
Screening & 6 weeks
2019-04-26
Participant Flow
Participant milestones
| Measure |
Screening Period
All study participants that were screened and signed consent.
|
AVAPS-AE
AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
Non-Invasive Ventilation (NIV) therapy modality in the OmniLab Advanced BiPAP.
|
Respironics OmniLab Advanced CPAP Mode
Non-Invasive Ventilation (NIV) therapy modality in the Respironics OmniLab Advanced CPAP
|
|---|---|---|---|---|
|
Screening Period
STARTED
|
90
|
0
|
0
|
0
|
|
Screening Period
COMPLETED
|
32
|
0
|
0
|
0
|
|
Screening Period
NOT COMPLETED
|
58
|
0
|
0
|
0
|
|
Study Period
STARTED
|
0
|
11
|
10
|
11
|
|
Study Period
COMPLETED
|
0
|
10
|
8
|
8
|
|
Study Period
NOT COMPLETED
|
0
|
1
|
2
|
3
|
Reasons for withdrawal
| Measure |
Screening Period
All study participants that were screened and signed consent.
|
AVAPS-AE
AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
Non-Invasive Ventilation (NIV) therapy modality in the OmniLab Advanced BiPAP.
|
Respironics OmniLab Advanced CPAP Mode
Non-Invasive Ventilation (NIV) therapy modality in the Respironics OmniLab Advanced CPAP
|
|---|---|---|---|---|
|
Screening Period
Screen Failure
|
58
|
0
|
0
|
0
|
|
Study Period
Withdrawal by Subject
|
0
|
1
|
1
|
3
|
|
Study Period
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
AVAPS-AE Efficacy Study
Baseline characteristics by cohort
| Measure |
All Study Participants
n=90 Participants
All study participants that signed the consent are included in the baseline characteristics to due the high screen failure rate and large number of participants that discontinued the study.
|
|---|---|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
49.3 kg/m^2
STANDARD_DEVIATION 10.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Screening & 6 weeksPopulation: 6 participants withdrew from the study and therefore did not provide values at week 6.
Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.
Outcome measures
| Measure |
AVAPS-AE
n=11 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=11 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
Screening
|
47.1 mmHg
Standard Deviation 2.5
|
51.8 mmHg
Standard Deviation 8.0
|
50.7 mmHg
Standard Deviation 4.7
|
|
Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
Week 6
|
40.7 mmHg
Standard Deviation 3.7
|
47.4 mmHg
Standard Deviation 8.9
|
40.8 mmHg
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Screening & 6 weeksPopulation: 6 participants withdrew from the study and therefore did not provide values at week 6.
Daytime Pa02 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.
Outcome measures
| Measure |
AVAPS-AE
n=11 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=11 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02)
Screening
|
62.8 mmHg
Standard Deviation 5.8
|
56.9 mmHg
Standard Deviation 10.7
|
62.6 mmHg
Standard Deviation 9.8
|
|
Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02)
Week 6
|
65.0 mmHg
Standard Deviation 4.5
|
58.7 mmHg
Standard Deviation 14.7
|
66.2 mmHg
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Screening & 6 weeksPopulation: 6 participants withdrew from the study and therefore did not provide values at week 6. 1 Participant did not have scorable data from the baseline PSG to calculate this measure.
The AHI is the number of apneas and hypopneas per hour of sleep. It will be evaluated during the screening sleep study and the 6 week follow up sleep study. AHI less than 5 is considered normal. For an Apnea-Hypopnea Index (or AHI) from 5 to 15 denotes mild sleep apnea. Fifteen to 30 is moderate, while a greater than 30 AHI is considered severe.
Outcome measures
| Measure |
AVAPS-AE
n=11 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=10 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Apnea Hypopnea Index (AHI)
Screening
|
84.5 events per hour
Standard Deviation 37.9
|
67.7 events per hour
Standard Deviation 23.9
|
85.4 events per hour
Standard Deviation 33.5
|
|
Apnea Hypopnea Index (AHI)
Titration
|
16.1 events per hour
Standard Deviation 11.6
|
22.4 events per hour
Standard Deviation 11.1
|
30.1 events per hour
Standard Deviation 23.6
|
|
Apnea Hypopnea Index (AHI)
Week 6
|
15.5 events per hour
Standard Deviation 11.8
|
12.4 events per hour
Standard Deviation 14.8
|
7.4 events per hour
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Screening & 6 weeksPopulation: 6 participants withdrew from the study and therefore did not provide values at week 6. 1 participant did not complete the ESS at the end of the study.
Epworth Sleepiness scale is a measure of daytime sleepiness. It is a series of 8 questions answered on a scale of 0 to 3, 0 being no chance of dozing and 3 being a high chance of dozing. The range of the scale is 0 to 24. The higher the total score, the higher the chance of falling asleep.
Outcome measures
| Measure |
AVAPS-AE
n=11 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=11 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Epworth Sleepiness Scale
Week 6
|
9.8 units on a scale
Standard Deviation 5.8
|
8.1 units on a scale
Standard Deviation 6.1
|
5.9 units on a scale
Standard Deviation 5.0
|
|
Epworth Sleepiness Scale
Screening
|
14.9 units on a scale
Standard Deviation 4.8
|
12.0 units on a scale
Standard Deviation 5.2
|
11.5 units on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Screening & 6 weeksPopulation: 6 participants withdrew from the study and therefore did not provide values at week 6.
The SRIQ is a 49 question survey. This survey asks questions about the past week. It is answered on a scale of -2 to 2 and converted to 1 to 5, 1 is completely untrue and 5 is always true. The questionnaire is broken down into 7 sections when scoring: respiratory complaints, physical functioning, attendant systems and sleep, social relationships, anxiety, psychological well-being and social functioning. Once each scale score is calculated. The average score can be calculated by taking the mean of the subscales. This process of transformation produces a score between 0 and 100 with higher values indicating a better health-related quality of life according to content of the scale.
Outcome measures
| Measure |
AVAPS-AE
n=11 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=11 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Severe Respiratory Insufficiency Questionnaire (SRIQ)
Screening
|
52.0 units on a scale
Standard Deviation 14.5
|
53.4 units on a scale
Standard Deviation 14.5
|
60.0 units on a scale
Standard Deviation 16.1
|
|
Severe Respiratory Insufficiency Questionnaire (SRIQ)
Week 6
|
61.0 units on a scale
Standard Deviation 13.5
|
64.8 units on a scale
Standard Deviation 18.4
|
69.7 units on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: 6 participants withdrew from the study and therefore did not provide values at week 6.
The average number of hours ventilator was used per each day used.
Outcome measures
| Measure |
AVAPS-AE
n=10 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=8 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=8 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Ventilator Adherence - Average Hours
|
4.8 Hours per day
Standard Deviation 0.9
|
5.2 Hours per day
Standard Deviation 1.7
|
6.6 Hours per day
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: 6 participants withdrew from the study and therefore did not provide values at week 6.
Average number of days used per week
Outcome measures
| Measure |
AVAPS-AE
n=10 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=8 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=8 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Ventilator Adherence - Days Used
|
5.3 days per week
Standard Deviation 0.9
|
5.3 days per week
Standard Deviation 1.5
|
6.9 days per week
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Screening & 6 weeksPopulation: Participants were asked to wear an actiwatch to measure actigraphy. Actigraphy was reviewed as part of the study however a detailed analysis was not conducted because the data was to variable.
Actigraphy is a method of measuring activity and sleep which is achieved by wearing a small watch-like device for an extended period of time. The data is intended to provide an objective measure of physical activity and sleep / week patterns during pre / post sleep studies and throughout the 6 weeks of home use.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening & 6 weeksPopulation: 6 participants withdrew from the study and therefore did not provide values at week 6.
Oxygen saturation measurements as determined by pulse oximetry
Outcome measures
| Measure |
AVAPS-AE
n=11 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=11 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Room Air Sp02 Assessment Via Pulse Oximetry
Screening
|
92.5 percentage of oxygen saturation (SpO2)
Standard Deviation 3.4
|
90.6 percentage of oxygen saturation (SpO2)
Standard Deviation 4.1
|
92.9 percentage of oxygen saturation (SpO2)
Standard Deviation 2.5
|
|
Room Air Sp02 Assessment Via Pulse Oximetry
Week 6
|
94.6 percentage of oxygen saturation (SpO2)
Standard Deviation 2.0
|
90.1 percentage of oxygen saturation (SpO2)
Standard Deviation 7.2
|
94.1 percentage of oxygen saturation (SpO2)
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Screening & 6 weeksPopulation: This measure was not a standard practice of the sleep scoring company and was not done.
Nocturnal Transcutaneous Capnography is a non-invasive monitoring tool to measure ventilation over the night. .
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening & 6 weeksPopulation: 6 participants withdrew from the study and therefore did not provide values at week 6. 1 Participant did not have scorable data from the baseline PSG to calculate this measure.
Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Total sleep time in each stage provides the average amount of time a participant was in that stage of sleep. This includes Stage 1, Stage 2, Stage 3/4, and Rapid Eye Movement (REM) sleep.
Outcome measures
| Measure |
AVAPS-AE
n=11 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=10 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration
Total Sleep Time Stage 1- Screening
|
28.4 percentage of time spent in that stage
Standard Deviation 19.5
|
24.6 percentage of time spent in that stage
Standard Deviation 26.6
|
18.9 percentage of time spent in that stage
Standard Deviation 15.6
|
|
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration
Total Sleep Time Stage 1- 6 weeks
|
10.0 percentage of time spent in that stage
Standard Deviation 6.8
|
13.1 percentage of time spent in that stage
Standard Deviation 10.3
|
10.1 percentage of time spent in that stage
Standard Deviation 7.3
|
|
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration
Total Sleep Time Stage 2- Screening
|
50.8 percentage of time spent in that stage
Standard Deviation 15.8
|
59.1 percentage of time spent in that stage
Standard Deviation 22.4
|
64.8 percentage of time spent in that stage
Standard Deviation 15.8
|
|
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration
Total Sleep Time Stage 2-6 weeks
|
59.2 percentage of time spent in that stage
Standard Deviation 15.1
|
52.4 percentage of time spent in that stage
Standard Deviation 14.3
|
53.2 percentage of time spent in that stage
Standard Deviation 15.4
|
|
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration
Total Sleep Time Stage 3/4 - Screening
|
8.5 percentage of time spent in that stage
Standard Deviation 13.7
|
8.1 percentage of time spent in that stage
Standard Deviation 11.7
|
7.8 percentage of time spent in that stage
Standard Deviation 8.4
|
|
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration
Total Sleep Time Stagev3/4-6 weeks
|
12.5 percentage of time spent in that stage
Standard Deviation 13.2
|
14.0 percentage of time spent in that stage
Standard Deviation 10.9
|
16.6 percentage of time spent in that stage
Standard Deviation 15.8
|
|
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration
Total Sleep Time Stage REM- Screening
|
13.5 percentage of time spent in that stage
Standard Deviation 7.4
|
8.2 percentage of time spent in that stage
Standard Deviation 10.1
|
8.5 percentage of time spent in that stage
Standard Deviation 5.1
|
|
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration
Total Sleep Time Stage REM-6 weeks
|
18.3 percentage of time spent in that stage
Standard Deviation 8.9
|
20.4 percentage of time spent in that stage
Standard Deviation 9.1
|
20.1 percentage of time spent in that stage
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Screening & 6 weeksPopulation: 6 participants withdrew from the study and therefore did not provide values at week 6. 1 Participant did not have scorable data from the baseline PSG to calculate this measure.
Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Sleep efficiency is measured by the total time a participant is spent asleep.
Outcome measures
| Measure |
AVAPS-AE
n=11 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=10 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency
Sleep Efficiency - Screening
|
74.4 percentage of time spent in that stage
Standard Deviation 14.9
|
64.5 percentage of time spent in that stage
Standard Deviation 14.9
|
74.6 percentage of time spent in that stage
Standard Deviation 18.9
|
|
Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency
Sleep Efficiency - 6 weeks
|
86.8 percentage of time spent in that stage
Standard Deviation 8.4
|
71.4 percentage of time spent in that stage
Standard Deviation 17.1
|
74.4 percentage of time spent in that stage
Standard Deviation 23.8
|
SECONDARY outcome
Timeframe: Screening & 6 weeksPopulation: 6 participants withdrew from the study and therefore did not provide values at week 6. 1 Participant did not have scorable data from the baseline PSG to calculate this measure.
The arousal index is measured by the average number of arousals or awakenings a participant has over an hour of sleep.
Outcome measures
| Measure |
AVAPS-AE
n=11 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=10 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices
Screening
|
68.2 arousals per hour
Standard Deviation 31.2
|
66.0 arousals per hour
Standard Deviation 20.9
|
71.4 arousals per hour
Standard Deviation 27.1
|
|
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices
6 weeks
|
19.4 arousals per hour
Standard Deviation 9.3
|
23.0 arousals per hour
Standard Deviation 10.9
|
21.3 arousals per hour
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Screening & 6 weeksPopulation: 6 participants withdrew from the study and therefore did not provide values at week 6. 1 Participant did not have scorable data from the baseline PSG to calculate this measure.
Measurement of overnight oxygen saturation as measured by percentage of oxygen saturation (SpO2)
Outcome measures
| Measure |
AVAPS-AE
n=11 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=10 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation
Screening
|
84.2 percentage of oxygen saturation (SpO2)
Standard Deviation 6.0
|
81.6 percentage of oxygen saturation (SpO2)
Standard Deviation 7.5
|
81.1 percentage of oxygen saturation (SpO2)
Standard Deviation 8.5
|
|
Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation
6 weeks
|
92.7 percentage of oxygen saturation (SpO2)
Standard Deviation 2.5
|
93.3 percentage of oxygen saturation (SpO2)
Standard Deviation 2.9
|
94.5 percentage of oxygen saturation (SpO2)
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Screening & 6 weeksPopulation: 1. participant from the AVAPS-AE Arm/Group did not complete the baseline screening PVT. 2. participants from the Omnilab Advanced BIPAP Arm/Group did not complete the 6 week follow up PVT. 3. participants from the Omnilab Advanced CPAP Arm/Group did not complete the 6 week follow up PVT.
To measure trends of vigilance between the baseline screening assessment and the 6 week follow up visit comparing the three Arms/Groups. This measured how quickly participants reacted to visual stimulus. Reaction time is the latency at which the participant reacts to a visual stimulus \> 100 ms.
Outcome measures
| Measure |
AVAPS-AE
n=9 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=8 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=8 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Reaction Time (Psychomotor Vigilance Test-PVT)
Screening
|
3987.13 milliseconds
Standard Deviation 8441.71
|
4752.75 milliseconds
Standard Deviation 11435.85
|
4523.25 milliseconds
Standard Deviation 10820.36
|
|
Reaction Time (Psychomotor Vigilance Test-PVT)
6 weeks
|
2978.89 milliseconds
Standard Deviation 7133.21
|
5681.83 milliseconds
Standard Deviation 12593.01
|
6705.20 milliseconds
Standard Deviation 13840.41
|
SECONDARY outcome
Timeframe: Screening & 6 weeksSome users enrolled into the study required supplemental oxygen at different times during the day: at rest, during exertion and at night. The need for supplemental oxygen was compared at baseline and at 6 weeks.
Outcome measures
| Measure |
AVAPS-AE
n=11 Participants
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 Participants
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=11 Participants
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Number of Participants With Need for Continued Oxygen Supplementation
At Exertion- Screening
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Need for Continued Oxygen Supplementation
At Rest- Screening
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Need for Continued Oxygen Supplementation
At Rest-6 weeks
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Need for Continued Oxygen Supplementation
At Sleep- Screening
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Need for Continued Oxygen Supplementation
At Sleep- 6 weeks
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Need for Continued Oxygen Supplementation
At Exertion- 6 weeks
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
AVAPS-AE
Respironics OmniLab Advanced BiPAP S Mode
Respironics OmniLab Advanced CPAP Mode
Serious adverse events
| Measure |
AVAPS-AE
n=11 participants at risk
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 participants at risk
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=11 participants at risk
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Cardiac disorders
Chest Pain
|
0.00%
0/11 • All Adverse Events experienced over 6 weeks were collected.
|
0.00%
0/10 • All Adverse Events experienced over 6 weeks were collected.
|
9.1%
1/11 • Number of events 1 • All Adverse Events experienced over 6 weeks were collected.
|
|
Renal and urinary disorders
Fournier's Gangrene
|
0.00%
0/11 • All Adverse Events experienced over 6 weeks were collected.
|
0.00%
0/10 • All Adverse Events experienced over 6 weeks were collected.
|
9.1%
1/11 • Number of events 1 • All Adverse Events experienced over 6 weeks were collected.
|
Other adverse events
| Measure |
AVAPS-AE
n=11 participants at risk
AVAPS-AE Mode of ventilation
AVAPS-AE Mode of Therapy: AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
|
Respironics OmniLab Advanced BiPAP S Mode
n=10 participants at risk
OmniLab Advanced BiPAP S Mode of ventilation
Respironics OnmiLab BiPAP S mode: Currently cleared NIV therapy modality
|
Respironics OmniLab Advanced CPAP Mode
n=11 participants at risk
OmniLab Advanced CPAP Mode of ventilation
Respironics OmniLab Advanced CPAP mode: Currently cleared NIV therapy modality
|
|---|---|---|---|
|
Cardiac disorders
Chest Pain
|
9.1%
1/11 • Number of events 1 • All Adverse Events experienced over 6 weeks were collected.
|
0.00%
0/10 • All Adverse Events experienced over 6 weeks were collected.
|
9.1%
1/11 • Number of events 1 • All Adverse Events experienced over 6 weeks were collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place