An interventional study of Philips BiPAP AutoSV Advanced System One and Modified Philips BiPAP ASV in Sleep Apnea Syndromes, sponsored by Philips Respironics. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-03-19.
Sponsored by Philips Respironics · Not applicable, Interventional, and Treatment
Continuous Positive Airway Pressure (CPAP) is the most effective treatment for the Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS). CPAP stabilizes the airway and prevents instability and collapse. With a stable and patent airway, breathing continues in a normal manner, gas exchange is improved, and there is no disruption of sleep related to disturbed breathing.
Auto Servo Ventilation (Auto SV) is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. The main features of the Auto SV mode include:
Several manufacturers produce these types of devices. The algorithms used to determine the IPAP, EPAP and minimum respiratory rate are different. The largest number of these devices currently in use are the BiPAP AutoSV Advanced System One (Philips Respironics, Murrysville PA) and the Variable positive airway pressure (VPAP) Adapt (ResMed Corp., San Diego CA).
This study is to better understand the performance and features of the BiPAP autoSV Advanced System One. Philips Respironics will evaluate the PolySomnoGraphy (PSG) and Encore data from each night. The aim of the study is to characterize the acute outcomes of treatment provided by the device and evaluate any modifications made to the Philips Respironics device's algorithm
The participants for this study will be experienced in having used servo ventilation therapy at their home because it is only such patients who are already using servo ventilation as part of routine clinical care that are eligible for participation.
Participants will receive four (4) randomized PSG's during which they will receive treatment from the following devices in a randomized manner:
The participants sought for this effort will be previously prescribed a servo-ventilation device as part of routine clinical care.
Baseline with PSG
Research Trial PSG- Randomized to one of the four devices (4 research PSGs will be performed for each subject).
30 day Take Home with Modified Philips BiPAP ASV device
After the last PSG participants will be sent home on Modified Philips Auto Servo Ventilation (ASV) study device. A wireless modem with oxygen saturation level (SPO2) connection will be connected to the Modified Philips ASV study device. The wireless modem with SPO2 connection is for device data collection/transmission purposes only that monitors the usage and performance of the device in the home-setting.
The device setting should be set to the following:
After 30 day Take Home Participants Will
Additional Take Home with the Modified Philips BiPAP ASV device:
After trial completion:
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 25 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Philips Respironics is the lead sponsor of 40 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The Bi-Level Positive Airway Pressure system will be used and will be configured with these settings. P max: 30 EPAP min: 4 EPAPmax: 15 Pressure Support (PS) min: 0 Pressure Support (PS) max: 15 BiFlex: 2 Rate: Auto
Device: Philips BiPAP AutoSV Advanced System One
The modified Philips BiPAP ASV will be configured with these settings P max: 30 EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 15 BiFlex: 2 Rate: Auto
Device: Modified Philips BiPAP ASV
This is an FDA approved device and the following settings will be administered: End-expiratory Pressure (EEP): 4 PSmin: 3 PSMax: 16
Device: ResMed S7 VPAP Adapt
This is an FDA approved device and the following settings will be administered: EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 20 Max Ramp: Off
Device: ResMed S9 VPAP Adapt
Auto SV Auto Servo Ventilation is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. This devices is FDA approved and will be set according to a predetermined setting.
This Modified BiPAP ASV will be set to a predetermined setting. This is the investigational device.
This device is FDA approved and will be set to predetermined setting.
This device is FDA approved and will be set to predetermined setting.
Average Apnea Hypopnea Index Among Different Polysomnography Devices.
The Apnea Hypopnea Index is the number of the apneas and hypopneas during one hour of sleep. The average of these events over one night were compared during each overnight device use.
Time frame: 4 nights
A multi-site study that accrued over 2016 and into the middle of 2017.
| Milestone | Screening |
|---|---|
| Started | 25 |
| Completed | 15 |
| Not completed | 10 |
| Withdrew: Screen failure | 10 |
| Milestone | Screening |
|---|---|
| Started | 15 |
| Modified philips bipap asv | 13 |
| Resmed s7 vpap adapt | 13 |
| Philips bipap autosv advanced system one | 12 |
| Resmed s9 vpap adapt | 12 |
| Completed | 13 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Reason not given | 1 |
| Milestone | Screening |
|---|---|
| Started | 13 |
| Completed | 13 |
| Not completed | 0 |
The Apnea Hypopnea Index is the number of the apneas and hypopneas during one hour of sleep. The average of these events over one night were compared during each overnight device use.
| events per hour | Philips BiPAP AutoSV Advanced System One | Modified Philips BiPAP ASV | ResMed S7 VPAP Adapt | ResMed S9 VPAP Adapt |
|---|---|---|---|---|
| Average Apnea Hypopnea Index Among Different Polysomnography Devices. | 18.4 ± 23.0 | 25.4 ± 25 | 24.1 ± 25.4 | 19.2 ± 23.1 |
Collected over 40 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Philips BiPAP AutoSV Advanced System One | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| Modified Philips BiPAP ASV | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| ResMed S7 VPAP Adapt | 0/13 (0%) | 0/13 (0%) | 3/13 (23.1%) |
| ResMed S9 VPAP Adapt | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Take Home - Modified Philips BiPAP ASV | 0/13 (0%) | 0/13 (0%) | 1/13 (7.7%) |
| Event | Philips BiPAP AutoSV Advanced System One | Modified Philips BiPAP ASV | ResMed S7 VPAP Adapt | ResMed S9 VPAP Adapt | Take Home - Modified Philips BiPAP ASV |
|---|---|---|---|---|---|
| Paroxysmal Supraventricular TachycardiaCardiac disorders | 1/12 | 0/13 | 0/13 | 0/12 | 0/13 |
| EKG abnormalitiesCardiac disorders | 0/12 | 0/13 | 1/13 | 0/12 | 0/13 |
| seziureNervous system disorders | 0/12 | 0/13 | 0/13 | 0/12 | 1/13 |
| non-sustained ventricular tachycardiaCardiac disorders | 0/12 | 0/13 | 1/13 | 0/12 | 0/13 |
| Supraventricular TachycardiaCardiac disorders | 0/12 | 0/13 | 1/13 | 0/12 | 0/13 |
Five participants screened failed prior to collecting demographic information.
| Age, Categorical(Participants) | Screening |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 10 |
| Age, Continuous(years) | Screening |
|---|---|
| Mean | 65.3 ± 12.6 |
| Sex: Female, Male(Participants) | Screening |
|---|---|
| Female | 3 |
| Male | 17 |
| Ethnicity (NIH/OMB)(Participants) | Screening |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Screening |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Screening |
|---|---|
| United States | 20 |
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Philips Respironics