Cheyne-Stokes RespirationNCT01199042
Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients
A study testing BiPAP autoSV Advanced in people with Cheyne-Stokes Respiration and Sleep Apnea, Central, run by Philips Respironics at 3 sites in United States.
Trial summary
Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or Complex Sleep Apnea. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Cheyne-Stokes Respiration, Sleep Apnea, Central
- What is being tested?
- BiPAP autoSV Advanced
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2010to May 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, ages 21-75.
- Able and willing to provide written informed consent.
- Diagnosis of Central Sleep Apnea such as Hunter Cheyne Stokes Breathing, Complex Sleep Apnea, or Central Apnea with current daily Opioid use or any other predominant central sleep apnea.
- For participants diagnosed with Hunter Cheyne Stokes Breathing, at least 3 cycles of crescendo-decrescendo breathing amplitude AND either a Central Apnea Index (CAI) ≥ 5/hour OR the crescendo-decrescendo cycles last at least 10 consecutive minutes from an attended Diagnostic Polysomnogram (PSG).
- For participants diagnosed with Central Sleep Apnea with current daily Opioid use or any other predominant central sleep apnea, an Apnea/Hypopnea Index (AHI) ≥ 15 and CAI > 5 from an attended Diagnostic PSG.
- For participants diagnosed with Complex Sleep Apnea, an AHI ≥ 15 and CAI > 5 from a CPAP titration.
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- Systolic blood pressure > 80 mm Hg at Visit 1.
- Agreement to undergo a full-night, attended Diagnostic PSG.
- Agreement to undergo a full-night, attended CPAP titration PSG.
- Agreement to undergo a full-night, attended BiPAP automatic Servo Ventilation (autoSV) Advanced titration PSG
Who cannot join
- Active participation in another interventional research study.
- Diagnosis of acute decompensated heart failure.
- Surgery of the upper airway, nose, sinus or middle ear within the last 90 days.
- Major medical or psychiatric condition that would interfere with the demands of the study or the ability to complete the study. For example, severe unstable chronic lung disease, neuromuscular disease, cancer, or end stage renal failure.
- Qualifying for or awaiting heart transplantation.
- Currently prescribed oxygen therapy (e.g. as needed, nocturnal, or continuous).
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- At home treatment with adapted Servo Ventilation (ASV) or Bilevel Positive Airway Pressure (PAP) therapies.
- Unable to use PAP therapies due to physical (e.g. facial structural abnormalities) or cognitive (e.g. dementia) issues.
- Participants in whom PAP therapy is medically contraindicated.
- Uncontrolled hypertension (systolic ≥ 200 mm Hg/diastolic ≥ 120 mm Hg).
- Narcolepsy.
- Untreated Restless Legs Syndrome.
- Periodic Limb Movement arousal index > 20/hr.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kentucky Research Group
Louisville, Kentucky, 40217
Sleepcare Diagnostics
Mason, Ohio, 45040
Gaylord Hospital - Gaylord Sleep Research
Wallingford, Connecticut, 06492
About this study
Official title: BiPAP (Automatic Servo Ventilation) autoSV Advanced in Central Apnea Patients
Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or Complex Sleep Apnea.
Read the detailed description
Participants who qualify will be scheduled for one full night, attended diagnostic PSG, one full night attended continuous positive airway pressure (CPAP) titration, and one full night attended BiPAP autoSV Advanced titration PSG. Participants will be provided a BiPAP autoSV Advanced to use at home for 90 days.
- Conditions
- Cheyne-Stokes Respiration, Sleep Apnea, Central
- Being tested
- BiPAP autoSV Advanced
- Medical subject headings
- Cheyne-Stokes Respiration, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiPAP autoSV AdvancedDevice
The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.
| Study group | Role | What they receive |
|---|---|---|
| BiPAP autoSV Advanced Device | Other | Positive airway pressure device Receives: Device: BiPAP autoSV Advanced |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/Hypopnea Index (AHI)
To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.
Measured: During a single night of polysomnography lasting up to 8 hours.
Secondary outcomes (3)
Epworth Sleepiness Scale
To determine if there are changes in subjective sleepiness on the Epworth Sleepiness Scale (ESS) between Baseline (Visit 1) and 3 months (Visit 6). The ESS is an 8 question survey that determines sleepiness, each question is rated as a 0-3 will the total score ranging from 0-24.
Interpretation:
Score 0-7: Unlikely that there is abnormal sleep Score 8-9: Average amount of daytime sleepiness Score 10-15: Possible excessive sleepiness depending on the situation. Patient may want to consider seeking medical attention.
Score 16-24: Excessive sleepiness and patient should consider seeking medical attention
A decrease in the score indicates improvements in a patients overall sleepiness. An increase in the score indicates increased sleepiness.
Measured: 3 months
Breathing Event Indexes
To determine if there are changes in breathing event indexes (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to assess therapy efficacy.
Values were determined by taking the average of the first 7 days of treatment and comparing them to the average of the last 7 days of treatment.
Measured: from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment
Average Therapy Pressure Values
To compare BiPAP autoSV Advanced therapy pressure values (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to determine if pressure requirements change over time.
This analysis compares the average pressure support of the first week compared to the average pressure support to the final week.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2013
- Study completionMay 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cheyne-Stokes RespirationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 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 Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199042
- Sponsor's protocol ID
- ST-1001-ASVWO-MS
- Status last verified
- Mar 2016
- First submitted
- 9 Sep 2010
- Last updated
- 28 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Javaheri S, Winslow D, McCullough P, Wylie P, Kryger MH. The Use of a Fully Automated Automatic Adaptive Servoventilation Algorithm in the Acute and Long-term Treatment of Central Sleep Apnea. Chest. 2015 Dec;148(6):1454-1461. doi: 10.1378/chest.14-2966.
PubMed 25950507
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiPAP (Automatic Servo Ventilation) autoSV Advanced in Central Apnea Patients
- ClinicalTrials.gov ID
- NCT01199042
- Acronym / sponsor ID
- ST-1001-ASVWO-MS
- Conditions
- Cheyne-Stokes Respiration, Sleep Apnea, Central
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Posted 28 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or Complex Sleep Apnea.
Detailed description
Participants who qualify will be scheduled for one full night, attended diagnostic PSG, one full night attended continuous positive airway pressure (CPAP) titration, and one full night attended BiPAP autoSV Advanced titration PSG. Participants will be provided a BiPAP autoSV Advanced to use at home for 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BiPAP autoSV Advanced Device | Other | Device: BiPAP autoSV AdvancedPositive airway pressure device |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females, ages 21-75.
- Able and willing to provide written informed consent.
- Diagnosis of Central Sleep Apnea such as Hunter Cheyne Stokes Breathing, Complex Sleep Apnea, or Central Apnea with current daily Opioid use or any other predominant central sleep apnea.
- Systolic blood pressure > 80 mm Hg at Visit 1.
- Agreement to undergo a full-night, attended Diagnostic PSG.
Key exclusion criteria (13 listed)
- Active participation in another interventional research study.
- Diagnosis of acute decompensated heart failure.
- Surgery of the upper airway, nose, sinus or middle ear within the last 90 days.
- Major medical or psychiatric condition that would interfere with the demands of the study or the ability to complete the study. For example, severe unstable chronic lung disease, neuromuscular disease, cancer, or end stage renal failure.
- Qualifying for or awaiting heart transplantation.
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 autoSV AdvancedThe sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night. | Device | BiPAP autoSV Advanced Device |
Primary outcome
Apnea/Hypopnea Index (AHI)
Time frame: During a single night of polysomnography lasting up to 8 hours.
To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.
3 secondary outcomes
Epworth Sleepiness Scale
Time frame: 3 months
Breathing Event Indexes
Time frame: from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment
Average Therapy Pressure Values
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25950507Javaheri S, Winslow D, McCullough P, Wylie P, Kryger MH. The Use of a Fully Automated Automatic Adaptive Servoventilation Algorithm in the Acute and Long-term Treatment of Central Sleep Apnea. Chest. 2015 Dec;148(6):1454-1461. doi: 10.1378/chest.14-2966.
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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
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 autoSV Advanced in people with Cheyne-Stokes Respiration 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 10 inclusion and 13 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 28 Apr 2016. 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 28 Apr 2016). 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: During a single night of polysomnography lasting up to 8 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01199042, which also lists 1 linked publication.
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 28 Apr 2016.