Sleep Disordered BreathingAUTOSV3NCT00720213
Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device
A study testing Respironics BiPAP autoSV2 and Respironics BiPAP autoSV3 in people with Sleep Disordered Breathing and Sleep Apnea, Central, run by Philips Respironics at 5 sites in United States.
Trial summary
This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Complex Sleep Apneas (Comp… Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disordered Breathing, Sleep Apnea, Central
- What is being tested?
- Respironics BiPAP autoSV2 and Respironics BiPAP autoSV3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2008to Jul 2009
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pre-Study Inclusion Criteria:
- Age 21-80
- Ability to provide consent
- Documentation of medical stability by investigator
- Enrollment Inclusion Criteria:
- Participants who, during the ambulatory polysomnography (PSG) study (Stardust), or in lab Diagnostic PSG demonstrated an Apnea Hypopnea Index (AHI) ≥10 or Central Apnea Index (CAI) ≥5
- or
- Participants who previously demonstrated Central sleep Apnea (CSA), with a CAI≥5 on Continuous Positive Airway Pressure (CPAP) titration.
Who cannot join
- • Participants who are acutely ill, medically complicated or who are medically unstable.
- Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women of child bearing potential).
- Participants in whom PAP therapy is otherwise medically contraindicated.
- Participants who are unwilling to wear CPAP
- Participants who are currently prescribed nocturnal oxygen use and are unable to forego oxygen during study nights.
- Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).
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- Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- Participants with untreated, non- Obstructive Sleep Apnea (OSA)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index > 15).
- Participants who are unwilling to participate in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ohio State University
Columbus, Ohio, 43210
Arkansas Center for Sleep Medicine
Little Rock, Arkansas, 72205
Sleepcare Diagnostics
Mason, Ohio, 45040
Mark G. Goetting
Portage, Michigan, 49024
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device
This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Complex Sleep Apneas (Comp SAS) no worse than its predecessor, the BiPAP auto Servo ventilation 2 (autoSV2) device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.
Read the detailed description
This study was conducted to evaluate the therapeutic performance of a new auto Servo Ventilation device (Philips Respironics autoSV Advanced) for the treatment of complex central sleep apnea (CompSA). The features of autoSV Advanced include an automatic expiratory pressure (EPAP) adjustment, an advanced algorithm for distinguishing open versus obstructed airway apnea, a modified auto backup rate which is proportional to subject's baseline breathing rate, and a variable inspiratory support. Our primary aim was to compare the performance of the advanced servo-ventilator (BiPAP autoSV Advanced) with conventional servo-ventilator (BiPAP autoSV) in treating central sleep apnea (CSA).
Study Design: A prospective, multicenter, randomized, controlled trial.
Setting: Five sleep laboratories in the United States.
Participants: Thirty-seven participants were included.
- Conditions
- Sleep Disordered Breathing, Sleep Apnea, Central
- Being tested
- Respironics BiPAP autoSV2, Respironics BiPAP autoSV3
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respironics BiPAP autoSV2Device
Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night.
Respironics BiPAP autoSV3Device
Also called Respironics BiPAP autoSV3 advanced
Respironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night.
| Study group | Role | What they receive |
|---|---|---|
| Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3 | Active comparator | Participants will be randomized to receive Respironics BiPAP autoSV2 first and Respironics BiPAP autoSV3 second. Receives: Device: Respironics BiPAP autoSV2; Device: Respironics BiPAP autoSV3 |
| Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2 | Experimental | Participants will be randomized to receive Respironics BiPAP autoSV3 first and Respironics BiPAP autoSV2. Receives: Device: Respironics BiPAP autoSV2; Device: Respironics BiPAP autoSV3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index
The number of apneas and hypopneas per hour of sleep. Apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds as determined using nasal-oral thermistor or device flow. Hypopneas is shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal.
A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour. The index is the average number for apneas+hyopneas per hour.
Measured: 2 nights
Secondary outcomes (16)
Apnea Hypopnea Index- REM and NREM
The number of apneas and hypopneas per hour of sleep while in REM (rapid eye movement) and in NREM (non-rapid eye movement)
A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour while in REM vs. NREM.
Measured: 2 nights
Central Apnea Index
The number of central apneas divided by the number of hours of sleep. Central apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds that is associated with the absence of inspiratory effort.
A central sleep scorer was utilized to review of the overnight PSGs and count the number of central apneas per hour.
Measured: 2 nights
Obstructive Apnea Index
Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by complete or partial obstructions of the upper airway.
A central sleep scorer was utilized to review of the overnight PSGs and count the number of obstructive apneas per hour.
Measured: 2 nights
Mixed Apnea Index
Mixed sleep apnea is a combination of both obstructive and central sleep apnea symptoms
A central sleep scorer was utilized to review of the overnight PSGs and count the number of mixed apneas per hour.
Measured: 2 nights
Hypopnea Index
Hypopneas are characterized by shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal.
A central sleep scorer was utilized to review of the overnight PSGs and count the number of hyopneas per hour.
Measured: 2 nights
Sleep Onset Latency
Sleep onset latency is the length of time that it takes to accomplish the transition from full wakefulness to sleep, normally to the lightest of the non-REM sleep stages. This found by reviewing the number of minutes in the PSG it took from lights off until the lightest non-REM sleep.
Measured: 2 nights
Rapid Eye Movement (REM) Onset Latency
Rapid eye movement latency is the time from the sleep onset to the first epoch of REM sleep; therefore, it depends on the patient's sleep latency.
Measured: 2 nights
Wake After Sleep Onset
Wake after sleep onset refers to periods of wakefulness occurring after defined sleep onset. This was calculated by adding the total number of minutes the participant was awake after sleep onset.
Measured: 2 nights
Total Sleep Time
Total sleep time is the total time the participant was asleep after sleep onset. This is calculated by adding the total number of minutes the participant was asleep during the night after sleep onset.
Measured: 2 nights
Sleep Efficiency
Sleep efficiency is a measure of how much a participant slept over the night. This is calculated by comparing the total sleep time and the total recording time * 100.
Measured: 2 nights
Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time.
These measures are the amount of time patients spent in each stage of sleep in minutes.
Measured: 2 nights
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST)
Measured: 2 nights
Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous']
The number of arousals and awakenings is registered in the study, and reported as a total number and as a frequency per hour of sleep, which is referred to as an index. The higher the arousal index, the more tired you are likely to feel, though people vary in their tolerance of sleep disruptions.
Measured: 2 nights
Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study)
Measure of oxygen saturation as measured by a pulse oximetry over the course of the night.
Measured: 2 nights
Apnea Hypopnea Index (REM, NREM and TST) Using Modified Hypopnea Rule.
This is the measure of the Apnea Hypopnea Index as measured by using a modified hypopnea rule. The modified hypopnea rule is a scoring change when AHI changes due to central vs obstructive apneas.
Measured: 2 nights
Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.
The AHI during epochs for which leak is determined to exist within acceptable limits occurs is the same calculation during AHI is normally calculated just in a 30 second (epoch) time period.
Measured: 2 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2009
- Study completionJul 2009
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 Disordered BreathingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jamie Goodwin, Principal investigator, University of ArizonaShahrokh Javaheri, MD, Principal investigator, Sleepcare DiagnosticsRami Khayat, MD, Principal investigator, Ohio State UnivercityMark Goetting, MD, Principal investigator, Sleep HealthPaul Wylie, MD, Principal investigator, Arkansas Center for Sleep Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720213
- Sponsor's protocol ID
- MR-0731-ASV3-MS
- Acronym
- AUTOSV3
- Status last verified
- Jan 2019
- First submitted
- 18 Jul 2008
- Last updated
- 29 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device
- ClinicalTrials.gov ID
- NCT00720213
- Acronym / sponsor ID
- AUTOSV3 / MR-0731-ASV3-MS
- Conditions
- Sleep Disordered Breathing, Sleep Apnea, Central
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Posted 29 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Complex Sleep Apneas (Comp SAS) no worse than its predecessor, the BiPAP auto Servo ventilation 2 (autoSV2) device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.
Detailed description
This study was conducted to evaluate the therapeutic performance of a new auto Servo Ventilation device (Philips Respironics autoSV Advanced) for the treatment of complex central sleep apnea (CompSA). The features of autoSV Advanced include an automatic expiratory pressure (EPAP) adjustment, an advanced algorithm for distinguishing open versus obstructed airway apnea, a modified auto backup rate which is proportional to subject's baseline breathing rate, and a variable inspiratory support. Our primary aim was to compare the performance of the advanced servo-ventilator (BiPAP autoSV Advanced) with conventional servo-ventilator (BiPAP autoSV) in treating central sleep apnea (CSA).
Study Design: A prospective, multicenter, randomized, controlled trial.
Setting: Five sleep laboratories in the United States.
Participants: Thirty-seven participants were included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3 | Active comparator | Device: Respironics BiPAP autoSV2, Device: Respironics BiPAP autoSV3Participants will be randomized to receive Respironics BiPAP autoSV2 first and Respironics BiPAP autoSV3 second. |
| Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2 | Experimental | Device: Respironics BiPAP autoSV2, Device: Respironics BiPAP autoSV3Participants will be randomized to receive Respironics BiPAP autoSV3 first and Respironics BiPAP autoSV2. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 21-80
- Ability to provide consent
- Documentation of medical stability by investigator
- Participants who, during the ambulatory polysomnography (PSG) study (Stardust), or in lab Diagnostic PSG demonstrated an Apnea Hypopnea Index (AHI) ≥10 or Central Apnea Index (CAI) ≥5
- or
Key exclusion criteria (9 listed)
- • Participants who are acutely ill, medically complicated or who are medically unstable.
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 |
|---|---|---|
| Respironics BiPAP autoSV2Respironics BiPAP autoSV2 is an Auto Servo Ventilation Device. This will be used on a randomized night. | Device | Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3, Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2 |
| Respironics BiPAP autoSV3Also: Respironics BiPAP autoSV3 advancedRespironics BiPAP autoSV3 is an Auto Servo Ventilation Device. This will be used on a randomized night. | Device | Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3, Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2 |
Primary outcome
Apnea Hypopnea Index
Time frame: 2 nights
The number of apneas and hypopneas per hour of sleep. Apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds as determined using nasal-oral thermistor or device flow. Hypopneas is shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour. The index is the average number for apneas+hyopneas per hour.
16 secondary outcomes
Apnea Hypopnea Index- REM and NREM
Time frame: 2 nights
Central Apnea Index
Time frame: 2 nights
Obstructive Apnea Index
Time frame: 2 nights
Mixed Apnea Index
Time frame: 2 nights
Hypopnea Index
Time frame: 2 nights
Sleep Onset Latency
Time frame: 2 nights
Rapid Eye Movement (REM) Onset Latency
Time frame: 2 nights
Wake After Sleep Onset
Time frame: 2 nights
Total Sleep Time
Time frame: 2 nights
Sleep Efficiency
Time frame: 2 nights
Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time.
Time frame: 2 nights
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST)
Time frame: 2 nights
Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous']
Time frame: 2 nights
Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study)
Time frame: 2 nights
Apnea Hypopnea Index (REM, NREM and TST) Using Modified Hypopnea Rule.
Time frame: 2 nights
Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.
Time frame: 2 nights
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jamie Goodwin principal investigator
University of Arizona
Shahrokh Javaheri, MD principal investigator
Sleepcare Diagnostics
Rami Khayat, MD principal investigator
Ohio State Univercity
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respironics BiPAP autoSV2 and Respironics BiPAP autoSV3 in people with Sleep Disordered Breathing and Sleep Apnea, Central, run by Philips Respironics at 5 sites 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 8 inclusion and 9 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 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 29 Jan 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?
Apnea Hypopnea Index (time frame: 2 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 29 Jan 2019.