Sleep Disordered BreathingSV3-STNCT01241604
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
A study testing BiPAP S/T and BiPAP Auto SV3 in people with Sleep Disordered Breathing, run by Philips Respironics at 1 site in United States.
Trial summary
This study is being undertaken to collect data from Respironics, Inc's BiPAP autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T device. 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
- What is being tested?
- BiPAP S/T and BiPAP Auto SV3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to 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
- Age 21-80.
- Ability to provide consent.
- Documentation of medical stability by investigator.
- Currently using BiPAP S/T (At least 4 weeks on therapy).
- Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration.
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 unwilling to wear PAP.
- Participants who are currently prescribed oxygen therapy.
- 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).
- 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 Periodic Limb Movement (PLM) Arousal Index > 15).
- Participants who are unwilling to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Med One Medical Sleep Laboratory
Salt Lake City, Utah, 84121
About this study
This study is being undertaken to collect data from Respironics, Inc's BiPAP autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T 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
Primary Hypothesis and end-point:
The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than when compared to the BiPAP S/T device with respect to:
- Apnea-Hypopnea Index (AHI)
Secondary Hypothesis and end-points:
The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than the BiPAP S/T device, with respect to:
- Sleep Variables
- REM, NREM and Total Sleep Time (TST) Indices
- Apnea Hypopnea Index (AHI)
- Center Apnea Index(CAI)
- Obstructive Apnea Index (OAI)
- Mixed Apnea Index (MAI)
- Hypopnea Index (HI)
- Sleep Onset Latency (SOL)
- REM Onset Latency (ROL)
- Wake After Sleep Onset (WASO)
- Total Sleep Time (TST)
- Sleep Efficiency (SE %)
- Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (in minutes)
- Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (% TST)
- Arousal Index [total, AH-related, PLM-related, 'spontaneous']
- Nocturnal oxygenation (measured by continuous pulse oximetry during sleep study)
- AHI (REM, NREM and TST) using modified hypopnea rule.
- AHI (REM, NREM and TST) during epochs for which leak is determined to exist within acceptable limits
- Conditions
- Sleep Disordered Breathing
- Being tested
- BiPAP S/T, BiPAP Auto SV3
- 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.
BiPAP S/TDevice
Also called Respironics BiPAP S/T
Mechanical Non-invasive Ventilation
BiPAP Auto SV3Device
Also called Respironics BiPAP auto SV Advanced
Auto Servo Ventilation Device
| Study group | Role | What they receive |
|---|---|---|
| Respironics BiPAP S/T | Active comparator | Control Arm using Respironics BiPAP S/T Receives: Device: BiPAP S/T |
| Respironics BiPAP Auto SV3 | Active comparator | Treatment arm using Respironics BiPAP Auto SV3 Receives: Device: BiPAP Auto SV3 |
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.
Measured: 2 nights
Secondary outcomes (17)
Apnea Hypopnea Index- REM
The apnea hypopneas index is the number of apneas and hypopneas per hour of sleep while in REM (Rapid eye movement sleep).
Measured: 2 nights
Central Apnea Index
The central apnea index is the number of central apneas divided by the number of hours of sleep.
Measured: 2 nights
Obstructive Apnea Index
The obstructive apnea index is the number of obstructive apneas per hour of sleep.
Measured: 2 nights
Mixed Apnea Index
The mixed apnea index is a combination of both obstructive and central sleep apnea symptoms per hour.
Measured: 2 nights
Hypopnea Index
The hypopnea index is number hypopneas per hour.
Measured: 2 nights
Sleep Onset Latency
Sleep Onset Latency is the amount of time it takes to fall asleep after the lights have been turned off.
Measured: 2 nights
REM Onset Latency
REM Onset Latency is the time it takes to fall into REM sleep.
Measured: 2 nights
Wake After Sleep Onset
Wake After Sleep Onset is the amount time a participant is awake after they have fallen asleep.
Measured: 2 nights
Total Sleep Time
Total Sleep time is total amount of time a participant is asleep from lights off to lights on.
Measured: 2 nights
Sleep Efficiency
Sleep Efficiency is the percentage of time spent asleep while in bed.
Measured: 2 nights
Periodic Limb Movement Index
The periodic limb movement is the number of periodic limb movements per hour of sleep.
Measured: 2 nights
Arousal Index
The arousal index is the number of arousals or awakenings per hour of sleep.
Measured: 2 nights
Stages N1,N2,N3 and REM (R) Sleep (% TST)
The average amount of time spent N1, N2, N3 and REM percent total sleep time per night.
Measured: 2 nights
Stages N1,N2,N3 and REM (R) Sleep (in Minutes)
The average amount of time spent N1, N2, N3 and REM in minutes per night.
Measured: 2 nights
Nocturnal Oxygenation Index
Measurement of oxygen saturation index over the course of the night as measured by continuous pulse oximetry. The oxygen saturation index is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline.
Measured: 2 nights
Apnea Hypopnea Index Using Modified Hypopnea Rule.
The apnea hypopnea index is the number of apneas and hypopneas that occur per hour of sleep using the modified hypopnea rule.
Measured: 2 nights
Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.
The number of apneas and hypopneas per hour of sleep during which the leak is determined to exist within acceptable limits.
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 posted16 Nov 2010 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: Sub par recruitment performance
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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brydon Grant, MD, Principal investigator, Medical Director of Med One Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241604
- Sponsor's protocol ID
- MR-0830-ASV3-ST-SS
- Acronym
- SV3-ST
- Status last verified
- Mar 2019
- First submitted
- 2 Jun 2009
- Last updated
- 9 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 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 Compared to BiPAP S/T Device
- ClinicalTrials.gov ID
- NCT01241604
- Acronym / sponsor ID
- SV3-ST / MR-0830-ASV3-ST-SS
- Conditions
- Sleep Disordered Breathing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sub par recruitment performance
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Posted 9 Apr 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 autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T 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
Primary Hypothesis and end-point:
The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than when compared to the BiPAP S/T device with respect to:
- Apnea-Hypopnea Index (AHI)
Secondary Hypothesis and end-points:
The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than the BiPAP S/T device, with respect to:
- Sleep Variables
- REM, NREM and Total Sleep Time (TST) Indices
- Apnea Hypopnea Index (AHI)
- Center Apnea Index(CAI)
- Obstructive Apnea Index (OAI)
- Mixed Apnea Index (MAI)
- Hypopnea Index (HI)
- Sleep Onset Latency (SOL)
- REM Onset Latency (ROL)
- Wake After Sleep Onset (WASO)
- Total Sleep Time (TST)
- Sleep Efficiency (SE %)
- Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (in minutes)
- Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep (% TST)
- Arousal Index [total, AH-related, PLM-related, 'spontaneous']
- Nocturnal oxygenation (measured by continuous pulse oximetry during sleep study)
- AHI (REM, NREM and TST) using modified hypopnea rule.
- AHI (REM, NREM and TST) during epochs for which leak is determined to exist within acceptable limits
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respironics BiPAP S/T | Active comparator | Device: BiPAP S/TControl Arm using Respironics BiPAP S/T |
| Respironics BiPAP Auto SV3 | Active comparator | Device: BiPAP Auto SV3Treatment arm using Respironics BiPAP Auto SV3 |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21-80.
- Ability to provide consent.
- Documentation of medical stability by investigator.
- Currently using BiPAP S/T (At least 4 weeks on therapy).
- Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration.
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 unwilling to wear PAP.
- Participants who are currently prescribed oxygen therapy.
- 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).
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 |
|---|---|---|
| BiPAP S/TAlso: Respironics BiPAP S/TMechanical Non-invasive Ventilation | Device | Respironics BiPAP S/T |
| BiPAP Auto SV3Also: Respironics BiPAP auto SV AdvancedAuto Servo Ventilation Device | Device | Respironics BiPAP Auto SV3 |
Primary outcome
Apnea Hypopnea Index
Time frame: 2 nights
The number of apneas and hypopneas per hour of sleep.
17 secondary outcomes
Apnea Hypopnea Index- REM
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
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
Periodic Limb Movement Index
Time frame: 2 nights
Arousal Index
Time frame: 2 nights
Stages N1,N2,N3 and REM (R) Sleep (% TST)
Time frame: 2 nights
Stages N1,N2,N3 and REM (R) Sleep (in Minutes)
Time frame: 2 nights
Nocturnal Oxygenation Index
Time frame: 2 nights
Apnea Hypopnea Index 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 9 Apr 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.
Brydon Grant, MD principal investigator
Medical Director of Med One Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiPAP S/T and BiPAP Auto SV3 in people with Sleep Disordered Breathing, 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: stopped early, as of the sponsor's last update on 9 Apr 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 9 Apr 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 9 Apr 2019.