Trial Outcomes & Findings for Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm (NCT NCT01403584)
NCT ID: NCT01403584
Last Updated: 2021-03-26
Results Overview
The AHI is a count of the number of pauses during sleep a person experiences. The total number of apneas/ hypopneas (sleep pauses) are divided by the total sleep time to get an index for that night
COMPLETED
NA
21 participants
On completion of each consecutive night of polysomnography.
2021-03-26
Participant Flow
Respiratory insufficiency and hypercapnia requiring noninvasive ventilation. Stable on bi-level CPAP. Both genders. Age \>18 and \<75years. Requiring EPAP \>5cmH2O for upper airway patency, or expected to (e.g. obese patients). Some known to have airway patency at EPAP of 5cmH2O will be included to test for falsely positive response.
Participant milestones
| Measure |
AutoVPAP With Addition of AutoEPAP
First AutoVPAP With addition of AutoEPAP then AutoVPAP with EPAP Manually Selected
Treatment period with conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure
AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation.
|
AutoVPAP With EPAP Manually Selected
"First AutoVPAP With EPAP Manually Selected then AutoVPAP With Addition of AutoEPAP.
A period of treatment using conventionally applied Expiratory Positive Airway Pressure
AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation.
|
|---|---|---|
|
First Intervention (1 Night)
STARTED
|
11
|
10
|
|
First Intervention (1 Night)
COMPLETED
|
11
|
10
|
|
First Intervention (1 Night)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention(1 Night)
STARTED
|
10
|
11
|
|
Second Intervention(1 Night)
COMPLETED
|
10
|
11
|
|
Second Intervention(1 Night)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
Baseline characteristics by cohort
| Measure |
All Participants
n=21 Participants
Treatment period with conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure
AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation.
|
|---|---|
|
Age, Customized
Age in years · 19-30
|
2 Participants
n=5 Participants
|
|
Age, Customized
Age in years · 31-40
|
0 Participants
n=5 Participants
|
|
Age, Customized
Age in years · 41-50
|
1 Participants
n=5 Participants
|
|
Age, Customized
Age in years · 51-60
|
7 Participants
n=5 Participants
|
|
Age, Customized
Age in years · 61-70
|
7 Participants
n=5 Participants
|
|
Age, Customized
Age in years · 71-80
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
21 count of participants
n=5 Participants
|
|
FEV1(%predicted)
|
37.5 %predicted
n=5 Participants
|
|
FEV1/FVC
|
52 %
n=5 Participants
|
PRIMARY outcome
Timeframe: On completion of each consecutive night of polysomnography.The AHI is a count of the number of pauses during sleep a person experiences. The total number of apneas/ hypopneas (sleep pauses) are divided by the total sleep time to get an index for that night
Outcome measures
| Measure |
Automatic Algorithm - AutoVPAP With Addition of AutoEPAP
n=21 Participants
Treatment period with conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure
AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation.
|
Conventional Therapy - AutoVPAP With EPAP Manually Selected
n=21 Participants
A period of treatment using conventionally applied Expiratory Positive Airway Pressure
AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation.
|
|---|---|---|
|
Index of Apneoas Plus Hypopnoeas Per Hour of Sleep (AHI)
|
1.3 Events per hour of sleep
Standard Deviation 2.3
|
1.7 Events per hour of sleep
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: On completion of each night of 2 consecutive nights polysomnography.During sleep, pulse oximetery is recorded through a sensor on the participants finger
Outcome measures
| Measure |
Automatic Algorithm - AutoVPAP With Addition of AutoEPAP
n=21 Participants
Treatment period with conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure
AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation.
|
Conventional Therapy - AutoVPAP With EPAP Manually Selected
n=21 Participants
A period of treatment using conventionally applied Expiratory Positive Airway Pressure
AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation.
|
|---|---|---|
|
Mean SpO2
|
92 Percent
Standard Deviation 3
|
93 Percent
Standard Deviation 3
|
Adverse Events
Automatic Algorithm - AutoVPAP With Addition of AutoEPAP
Conventional Therapy - AutoVPAP With EPAP Manually Selected
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