Sleep Disordered BreathingNCT01626989
Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders
A study testing BiPAP auto Advanced and BiPAP auto SV4 in people with Sleep Disordered Breathing and Sleep Apnea, Central, run by Philips Respironics at 3 sites in United States.
Trial summary
Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining if the new device will treat those participants no worse than when compared to its predecessor 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, Sleep Apnea, Central
- What is being tested?
- BiPAP auto Advanced and BiPAP auto SV4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2010to Jun 2012
- 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
- Subjects who currently have been on Positive Airway Pressure (PAP) therapy for ≥ 4 weeks and who previously had a Continuous Positive Airway Pressure (CPAP) titration with CAI ≥ 5.
- OR Subjects who currently have been on PAP therapy for ≥ 4 weeks and who had a diagnostic study done, with a CAI ≥ 5, and were prescribed PAP therapy without a CPAP titration.
- Agreement to undergo a full-night, in-lab research CPAP Titration
- Agreement to undergo two full-night, in-lab therapy research Polysomnography (PSG) on BiPAP autoSV devices
Who cannot join
- Major medical or psychiatric condition that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study. For example, unstable congestive heart failure, chronic lung disease, neuromuscular disease, daytime hypercapnia, cancer, or renal failure.
- Systolic blood pressure < 80 mm Hg at Baseline Visit.
- Participants in whom PAP therapy is otherwise medically contraindicated.
- Participants who are unwilling to wear CPAP
- Currently prescribed oxygen therapy (as needed, nocturnal, or continuous
- 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)/ Complex Sleep Apnea (CSA) sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index > 15).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Arkansas Center for Sleep Medicine
Little Rock, Arkansas, 72205
Sleepcare Diagnostics
Mason, Ohio, 45040
Sleep Health
Portage, Michigan, 49024
About this study
Official title: Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders.
Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining if the new device will treat those participants no worse than when compared to its predecessor device.
Read the detailed description
The use of the BiPAP autoSV4 device in participants with Complex Sleep Apnea Syndrome will treat those participants no worse than when compared to its predecessor device, the BiPAP autoSV Advanced™, with respect to:
- Apnea-Hypopnea Index (AHI)
- Conditions
- Sleep Disordered Breathing, Sleep Apnea, Central
- Being tested
- BiPAP auto Advanced, BiPAP auto SV4
- 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.
BiPAP auto AdvancedDevice
Also called BiPAP Auto SV
Auto Servo Ventilation Device
BiPAP auto SV4Device
Also called BiPAP Auto SV
Auto Servo Ventilation Device
| Study group | Role | What they receive |
|---|---|---|
| BiPAP auto SV Advanced | Active comparator | BiPAP auto SV Advanced Receives: Device: BiPAP auto Advanced |
| BiPAP auto SV 4 | Experimental | Auto Servo Ventilation Device Receives: Device: BiPAP auto SV4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.
Measured: Baseline, and 2 nights (1 night for each intervention)
Secondary outcomes (13)
Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices
REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Total Sleep Time (TST) is the duration of time from "lights out," or bedtime, to the onset of sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode
Measured: Baseline, and 2 nights (1 night for each intervention)
Central Apnea Index(CAI)
Central Apnea Index(CAI) is the number of central apneas divided by the number of hours of sleep.
Measured: Baseline, and 2 nights (1 night for each intervention)
Obstructive Apnea Index (OAI)
Obstructive Ap8 participants had missing or unscorable data, therefore they are not included in the analysis. nea Index (OAI) is the number of obstructive apneas divided by the number of hours of sleep.
Measured: Baseline, and 2 nights (1 night for each intervention)
Mixed Apnea Index (MAI)
Mixed Apnea Index (MAI) is the number of combination of central and obstructive apneas divided by the number of hours of sleep.
Measured: Baseline, and 2 nights (1 night for each intervention)
Sleep Onset Latency (SOL)
Sleep Onset Latency (SOL) is the amount of time it takes to fall asleep after the lights have been turned off.
Measured: Baseline, and 2 nights (1 night for each intervention)
REM Onset Latency (ROL)
REM Onset Latency (ROL) is defined as the time it takes to get into REM sleep from Sleep Onset.
Measured: Baseline, and 2 nights (1 night for each intervention)
Wake After Sleep Onset (WASO)
Wake After Sleep Onset (WASO) is a statistic used in sleep studies to determine the amount of time a person spends awake, starting from when they first fall asleep to when they become fully awake and do not attempt to go back to sleep.
Measured: Baseline, and 2 nights (1 night for each intervention)
Total Sleep Time (TST)
Total Sleep Time (TST). Total Sleep Time (TST) is the duration of time from "lights out," or bedtime, to waking from sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode
Measured: Baseline, and 2 nights (1 night for each intervention)
Sleep Efficiency (SE %)
Sleep Efficiency (SE %) is the percentage of time spent asleep while in bed.
Measured: Baseline, and 2 nights (1 night for each intervention)
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep. REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Wake (W) is the duration of time from "lights out," or bedtime, to the onset of sleep.
Measured: Baseline, and 2 nights (1 night for each intervention)
Arousal Index
Arousal Index is 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.
Measured: Baseline, and 2 nights (1 night for each intervention)
Nocturnal Oxygenation
Nocturnal oxygenation measured by continuous pulse oximetry during sleep study.
Measured: Baseline, and 2 nights (1 night for each intervention)
Hypopnea Index (HI)
Hypopnea Index (HI) is the number of hypopneas divided by number of hours of sleep.
Measured: Baseline, and 2 nights (1 night for each intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionJun 2012
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
- Shahrokh Javaheri, MD, Principal investigator, Sleepcare DiagnosticsPaul Wylie, MD, Principal investigator, Arkansas Center for Sleep MedicineMark Goetting, MD, Principal investigator, Sleep Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626989
- Sponsor's protocol ID
- ST-1007-ASV4-MS
- Status last verified
- Apr 2019
- First submitted
- 19 May 2011
- Last updated
- 25 Apr 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 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders.
- ClinicalTrials.gov ID
- NCT01626989
- Acronym / sponsor ID
- ST-1007-ASV4-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
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Jun 2012 (estimated)
- Results
- Posted 25 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining if the new device will treat those participants no worse than when compared to its predecessor device.
Detailed description
The use of the BiPAP autoSV4 device in participants with Complex Sleep Apnea Syndrome will treat those participants no worse than when compared to its predecessor device, the BiPAP autoSV Advanced™, with respect to:
- Apnea-Hypopnea Index (AHI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiPAP auto SV Advanced | Active comparator | Device: BiPAP auto AdvancedBiPAP auto SV Advanced |
| BiPAP auto SV 4 | Experimental | Device: BiPAP auto SV4Auto Servo Ventilation Device |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 21-80
- Ability to provide consent
- Documentation of medical stability by investigator
- Subjects who currently have been on Positive Airway Pressure (PAP) therapy for ≥ 4 weeks and who previously had a Continuous Positive Airway Pressure (CPAP) titration with CAI ≥ 5.
- OR Subjects who currently have been on PAP therapy for ≥ 4 weeks and who had a diagnostic study done, with a CAI ≥ 5, and were prescribed PAP therapy without a CPAP titration.
Key exclusion criteria (8 listed)
- Major medical or psychiatric condition that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study. For example, unstable congestive heart failure, chronic lung disease, neuromuscular disease, daytime hypercapnia, cancer, or renal failure.
- Systolic blood pressure < 80 mm Hg at Baseline Visit.
- Participants in whom PAP therapy is otherwise medically contraindicated.
- Participants who are unwilling to wear CPAP
- Currently prescribed oxygen therapy (as needed, nocturnal, or continuous
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 auto AdvancedAlso: BiPAP Auto SVAuto Servo Ventilation Device | Device | BiPAP auto SV Advanced |
| BiPAP auto SV4Also: BiPAP Auto SVAuto Servo Ventilation Device | Device | BiPAP auto SV 4 |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: Baseline, and 2 nights (1 night for each intervention)
Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.
13 secondary outcomes
Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices
Time frame: Baseline, and 2 nights (1 night for each intervention)
Central Apnea Index(CAI)
Time frame: Baseline, and 2 nights (1 night for each intervention)
Obstructive Apnea Index (OAI)
Time frame: Baseline, and 2 nights (1 night for each intervention)
Mixed Apnea Index (MAI)
Time frame: Baseline, and 2 nights (1 night for each intervention)
Sleep Onset Latency (SOL)
Time frame: Baseline, and 2 nights (1 night for each intervention)
REM Onset Latency (ROL)
Time frame: Baseline, and 2 nights (1 night for each intervention)
Wake After Sleep Onset (WASO)
Time frame: Baseline, and 2 nights (1 night for each intervention)
Total Sleep Time (TST)
Time frame: Baseline, and 2 nights (1 night for each intervention)
Sleep Efficiency (SE %)
Time frame: Baseline, and 2 nights (1 night for each intervention)
Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep
Time frame: Baseline, and 2 nights (1 night for each intervention)
Arousal Index
Time frame: Baseline, and 2 nights (1 night for each intervention)
Nocturnal Oxygenation
Time frame: Baseline, and 2 nights (1 night for each intervention)
Hypopnea Index (HI)
Time frame: Baseline, and 2 nights (1 night for each intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
Shahrokh Javaheri, MD principal investigator
Sleepcare Diagnostics
Paul Wylie, MD principal investigator
Arkansas Center for Sleep Medicine
Mark Goetting, MD principal investigator
Sleep Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiPAP auto Advanced and BiPAP auto SV4 in people with Sleep Disordered Breathing and Sleep Apnea, Central, run by Philips Respironics at 3 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 7 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 25 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 3 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 25 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 (AHI) (time frame: Baseline, and 2 nights (1 night for each intervention)). 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 25 Apr 2019.