Sleep Apnea SyndromesNCT02808338
Servo-Ventilation In-lab PSG Evaluation
A study testing Philips BiPAP AutoSV Advanced System One, Modified Philips BiPAP ASV and ResMed S7 VPAP Adapt in people with Sleep Apnea Syndromes, run by Philips Respironics at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Philips BiPAP AutoSV Advanced System One, Modified Philips BiPAP ASV and ResMed S7 VPAP Adapt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2015to 6 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide consent
- Age ≥ 21
- Currently prescribed servo ventilation therapy at home
- At least two weeks of recent adherence and efficacy data from PAP device demonstrating adequate use of therapy (at least 4 hours of use per night and use on at least 9 of 14 nights)
- Current device compliance report demonstrating residual Apnea-Hypopnea Index (AHI) of 5 or more
Who cannot join
- Participants who are acutely ill, medically complicated or who are medically unstable
- Participants in whom PAP therapy is otherwise medically contraindicated
- Participants who are claustrophobic
- Symptomatic ("Symptomatic" defined as hospitalized for heart failure or a change in cardiac medications, within the last two months) chronic heart failure (NYHA 2-4) and reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea
- Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 55mmHg).
- Participants requiring any kind of oxygen therapy
- Participants who have had surgery of the upper airway, nose, sinus, eyes, or middle ear within the previous 90 days
- Participants with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLMI > 10).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona School of Medicine
Tucson, Arizona, 85723
About this study
Official title: Servo-Ventilation In-lab Polysomnography (PSG) Evaluation
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:
Read more
- Normalization of ventilation by automatically adjusting Inspiratory Positive Airway Pressure (IPAP) pressure to achieve a target ventilation. IPAP is increased or decreased to help stabilize the ventilation.
- Provision of timed, back-up breaths during central apneas. The optimal back-up rate is automatically determined by the device based on the patient's breathing.
- Automatic control of Expiratory Positive Airway Pressure (EPAP) to treat obstructive events.
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).
Read the detailed description
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:
- FDA released Philips BiPAP AutoSV Advanced System One
- A Modified Philips BiPAP ASV
- FDA released ResMed S7 VPAP Adapt
- FDA released ResMed S9 VPAP Adapt
The participants sought for this effort will be previously prescribed a servo-ventilation device as part of routine clinical care.
Baseline with PSG
- Informed Consent
- Inclusion/Exclusion Criteria Review
- Demographics
- Anthropometric Measurements
- PAP Prescription information (if available; from Device or from Medical records). This is the pressure settings of the device that was prescribed by the patient's clinical sleep medicine provider.
- Medical History and physical examination
- Sleep History- Including that past 30 day detailed report
- Diagnostic PSG history (copies of sleep studies that were performed as part of routine clinical care in the past that qualified the patient for the servo-ventilation device)
- Current Medications
- Vital Signs (at beginning of PSG night)
- Research Trial PSG- Randomized to a device Procedures for Each PSG after Baseline
- Current Medications
- Vital Signs (at beginning of PSG night)
- 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:
- P max: 30
- EPAP min: 4
- Expiratory Positive Airway Pressure maximum (EPAPmax):15
- Pressure Support Minimum (PS min): 0
- Pressure Support Maximum (PS max): 15
- BiFlex (Bi-Level Flex): 2
- Rate: Auto
After 30 day Take Home Participants Will
- Return to the Sleep Lab
- Complete the end of study questionnaire
- Return all of the study equipment
Additional Take Home with the Modified Philips BiPAP ASV device:
- Participants may be asked to use the Modified Philips ASV study device for an additional 30 days if more data is needed for analysis. Participants will complete the same end of day questionnaire noted above.
After trial completion:
- When the Participant is done with the trial they will go back to using their own prescribed device.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Philips BiPAP AutoSV Advanced System One, Modified Philips BiPAP ASV, ResMed S7 VPAP Adapt, ResMed S9 VPAP Adapt
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips BiPAP AutoSV Advanced System OneDevice
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.
Modified Philips BiPAP ASVDevice
This Modified BiPAP ASV will be set to a predetermined setting. This is the investigational device.
ResMed S7 VPAP AdaptDevice
This device is FDA approved and will be set to predetermined setting.
ResMed S9 VPAP AdaptDevice
This device is FDA approved and will be set to predetermined setting.
| Study group | Role | What they receive |
|---|---|---|
| Philips BiPAP AutoSV Advanced System One | Active comparator | 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 Receives: Device: Philips BiPAP AutoSV Advanced System One |
| Modified Philips BiPAP ASV | Experimental | 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 Receives: Device: Modified Philips BiPAP ASV |
| ResMed S7 VPAP Adapt | Active comparator | This is an FDA approved device and the following settings will be administered:
End-expiratory Pressure (EEP): 4 PSmin: 3 PSMax: 16 Receives: Device: ResMed S7 VPAP Adapt |
| ResMed S9 VPAP Adapt | Active comparator | 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 Receives: Device: ResMed S9 VPAP Adapt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start9 Nov 2015
- Primary completion31 May 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sairam Parthasarathy, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808338
- Sponsor's protocol ID
- ST-1517-ALE-MS
- Status last verified
- Feb 2019
- First submitted
- 7 Jun 2016
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Servo-Ventilation In-lab Polysomnography (PSG) Evaluation
- ClinicalTrials.gov ID
- NCT02808338
- Acronym / sponsor ID
- ST-1517-ALE-MS
- Conditions
- Sleep Apnea Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Posted 19 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Normalization of ventilation by automatically adjusting Inspiratory Positive Airway Pressure (IPAP) pressure to achieve a target ventilation. IPAP is increased or decreased to help stabilize the ventilation.
- Provision of timed, back-up breaths during central apneas. The optimal back-up rate is automatically determined by the device based on the patient's breathing.
- Automatic control of Expiratory Positive Airway Pressure (EPAP) to treat obstructive events.
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).
Detailed description
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:
- FDA released Philips BiPAP AutoSV Advanced System One
- A Modified Philips BiPAP ASV
- FDA released ResMed S7 VPAP Adapt
- FDA released ResMed S9 VPAP Adapt
The participants sought for this effort will be previously prescribed a servo-ventilation device as part of routine clinical care.
Baseline with PSG
- Informed Consent
- Inclusion/Exclusion Criteria Review
- Demographics
- Anthropometric Measurements
- PAP Prescription information (if available; from Device or from Medical records). This is the pressure settings of the device that was prescribed by the patient's clinical sleep medicine provider.
- Medical History and physical examination
- Sleep History- Including that past 30 day detailed report
- Diagnostic PSG history (copies of sleep studies that were performed as part of routine clinical care in the past that qualified the patient for the servo-ventilation device)
- Current Medications
- Vital Signs (at beginning of PSG night)
- Research Trial PSG- Randomized to a device Procedures for Each PSG after Baseline
- Current Medications
- Vital Signs (at beginning of PSG night)
- 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:
- P max: 30
- EPAP min: 4
- Expiratory Positive Airway Pressure maximum (EPAPmax):15
- Pressure Support Minimum (PS min): 0
- Pressure Support Maximum (PS max): 15
- BiFlex (Bi-Level Flex): 2
- Rate: Auto
After 30 day Take Home Participants Will
- Return to the Sleep Lab
- Complete the end of study questionnaire
- Return all of the study equipment
Additional Take Home with the Modified Philips BiPAP ASV device:
- Participants may be asked to use the Modified Philips ASV study device for an additional 30 days if more data is needed for analysis. Participants will complete the same end of day questionnaire noted above.
After trial completion:
- When the Participant is done with the trial they will go back to using their own prescribed device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Philips BiPAP AutoSV Advanced System One | Active comparator | Device: Philips BiPAP AutoSV Advanced System OneThe 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 |
| Modified Philips BiPAP ASV | Experimental | Device: Modified Philips BiPAP ASVThe 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 |
| ResMed S7 VPAP Adapt | Active comparator | Device: ResMed S7 VPAP AdaptThis is an FDA approved device and the following settings will be administered: End-expiratory Pressure (EEP): 4 PSmin: 3 PSMax: 16 |
| ResMed S9 VPAP Adapt | Active comparator | Device: ResMed S9 VPAP AdaptThis 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide consent
- Age ≥ 21
- Currently prescribed servo ventilation therapy at home
- At least two weeks of recent adherence and efficacy data from PAP device demonstrating adequate use of therapy (at least 4 hours of use per night and use on at least 9 of 14 nights)
- Current device compliance report demonstrating residual Apnea-Hypopnea Index (AHI) of 5 or more
Key exclusion criteria (8 listed)
- Participants who are acutely ill, medically complicated or who are medically unstable
- Participants in whom PAP therapy is otherwise medically contraindicated
- Participants who are claustrophobic
- Symptomatic ("Symptomatic" defined as hospitalized for heart failure or a change in cardiac medications, within the last two months) chronic heart failure (NYHA 2-4) and reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea
- Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 55mmHg).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Philips BiPAP AutoSV Advanced System OneAuto 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. | Device | Philips BiPAP AutoSV Advanced System One |
| Modified Philips BiPAP ASVThis Modified BiPAP ASV will be set to a predetermined setting. This is the investigational device. | Device | Modified Philips BiPAP ASV |
| ResMed S7 VPAP AdaptThis device is FDA approved and will be set to predetermined setting. | Device | ResMed S7 VPAP Adapt |
| ResMed S9 VPAP AdaptThis device is FDA approved and will be set to predetermined setting. | Device | ResMed S9 VPAP Adapt |
Primary outcome
Average Apnea Hypopnea Index Among Different Polysomnography Devices.
Time frame: 4 nights
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sairam Parthasarathy, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Philips BiPAP AutoSV Advanced System One, Modified Philips BiPAP ASV and ResMed S7 VPAP Adapt in people with Sleep Apnea Syndromes, run by Philips Respironics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Apnea Hypopnea Index Among Different Polysomnography Devices. (time frame: 4 nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.