Periodic BreathingNCT01405313
Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV
A study testing Modified Adaptive Servoventilation Device and Conventional Adaptive Servoventilation device in people with Periodic Breathing and Breathing-Related Sleep Disorder, run by ResMed at 1 site in Germany.
Trial summary
This study will determine if modified adaptive servoventilation (ASV) is as effective as the conventional ASV in treating periodic breathing. The study will determine if the modified ASV reacts appropriately to reduce apneas and hypopneas and provides suitable levels of positive airway pressure compared to… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Periodic Breathing, Breathing-Related Sleep Disorder
- What is being tested?
- Modified Adaptive Servoventilation Device and Conventional Adaptive Servoventilation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Sep 2011
- 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
- 21+ years old
- Chronic ResMed ASV therapy patient
- Current ASV therapy for at least 4 weeks
- Able to understand fully the study information and participation requirements
- Provide signed informed consent
Who cannot join
- Acute cardiac decompensation
- Acute myocardial infarction within last 3 months
- Resuscitation within last 3 months
- Stroke with swallowing disorders or persistent hemiparesis
- Blood pressure test at end expiratory pressure (EEP) 10cmH2O not passed
- Untreated restless legs syndrome
Show all 10Show fewer
- Alcohol or drug abuse
- Known cancer
- Pregnancy
- Conditions that could interfere with patients participating in and completing the protocol and/or the investigator deems their enrolment unsuitable
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heart and Diabetes Centre, Ruhr University Bochum
Bad Oeynhausen, North Rhine-Westphalia, D-32545
About this study
Official title: Comparison of Modified Adaptive Servoventilation Therapy With Conventional Adaptive Servoventilation Therapy in Patients With Periodic Breathing
This study will determine if modified adaptive servoventilation (ASV) is as effective as the conventional ASV in treating periodic breathing. The study will determine if the modified ASV reacts appropriately to reduce apneas and hypopneas and provides suitable levels of positive airway pressure compared to conventional ASV.
Read the detailed description
Adaptive servoventilation (ASV) is a type of non-invasive ventilation which ameliorates central sleep and/or mixed apnea and periodic breathing. Previous studies in the field have shown that treatment of periodic breathing with ASV improves sleep quality and quality of life. In reducing central apneas, ASV reduces overall arousal index, and increases overall slow wave sleep and rapid eye movement (REM) sleep more than oxygen, continuous positive airway pressure or bi-level treatments. ASV can also more effectively reduce central apnea and overall apnea/hypopnea index (AHI) in patients on long-term opiates, and appears to effectively treat Complex Sleep Apnea Syndrome. It is more effective than other forms of non-invasive ventilation for patients with central and/or mixed apnea or periodic breathing, and is better tolerated.
This is a prospective, randomised, crossover, observational study. Subjects will spend one night on conventional ASV and one night on modified ASV with full in-lab polysomnography (PSG) during therapy on both nights.
Objective and subjective parameters will be recorded and analysed.
- Being tested
- Modified Adaptive Servoventilation Device, Conventional Adaptive Servoventilation device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Adaptive Servoventilation DeviceDevice
Also called ResMed Enhanced ASV, ASVAuto
The modified ASV has a greater adaptive response to meet a target ventilation level that is constantly being assessed.
Conventional Adaptive Servoventilation deviceDevice
Also called ResMed AutoSet CS2, ResMed VPAP Adapt SV, ResMed S9 VPAP Adapt
Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed.
| Study group | Role | What they receive |
|---|---|---|
| Modified ASV | Experimental | Modified ASV Enhanced ASV algorithm which includes auto-adjusting expiratory pressure. Receives: Device: Modified Adaptive Servoventilation Device |
| Conventional ASV | Active comparator | Conventional ASV This is the current (predicate) ASV algorithm. Receives: Device: Conventional Adaptive Servoventilation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/Hypopnea Index (AHI)
Physiological sleep signals including pulse oximetry (SpO2), respiratory effort and nasal flow, will be recorded, analysed and reported in the form of an index per hour of sleep. Apnea-Hypopnea Index is calculated counting all apneas (reduction of respiratory flow by >90% for at least 10 seconds) plus all hypopneas (reduction of respiratory flow by >30% for at least 10 seconds with a 4% SpO2 reduction) divided by hours of sleep.
Measured: One night
Secondary outcomes (1)
Oxygen Desaturation Index (ODI)
Oxygen desaturation index based on SpO2 measurement of number of dips (number of times per hour of sleep that SpO2 Drops by at least 3% below the basic value) will be recorded, analysed and reported.
Measured: One night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2011
- Study completionSep 2011
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 (6)Papers the sponsor has linked to this study.
- Other trials for Periodic 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
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olaf Oldenburg, MD, Principal investigator, Heart and Diabetes Centre, Ruhr University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405313
- Sponsor's protocol ID
- MA231210
- Status last verified
- Sep 2012
- First submitted
- 21 Jul 2011
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Teschler H, Dohring J, Wang YM, Berthon-Jones M. Adaptive pressure support servo-ventilation: a novel treatment for Cheyne-Stokes respiration in heart failure. Am J Respir Crit Care Med. 2001 Aug 15;164(4):614-9. doi: 10.1164/ajrccm.164.4.9908114.
PubMed 11520725Pepperell JC, Maskell NA, Jones DR, Langford-Wiley BA, Crosthwaite N, Stradling JR, Davies RJ. A randomized controlled trial of adaptive ventilation for Cheyne-Stokes breathing in heart failure. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1109-14. doi: 10.1164/rccm.200212-1476OC. Epub 2003 Aug 19.
PubMed 12928310Schadlich S, Konigs I, Kalbitz F, Blankenburg T, Busse HJ, Schutte W. [Cardiac efficiency in patients with Cheyne-Stokes respiration as a result of heart insufficiency during long-term nasal respiratory treatment with adaptive servo ventilation (AutoSet CS)]. Z Kardiol. 2004 Jun;93(6):454-62. doi: 10.1007/s00392-004-0083-3. German.
PubMed 15252739Oldenburg O, Schmidt A, Lamp B, Bitter T, Muntean BG, Langer C, Horstkotte D. Adaptive servoventilation improves cardiac function in patients with chronic heart failure and Cheyne-Stokes respiration. Eur J Heart Fail. 2008 Jun;10(6):581-6. doi: 10.1016/j.ejheart.2008.04.007. Epub 2008 May 16.
PubMed 18486550Javaheri S, Malik A, Smith J, Chung E. Adaptive pressure support servoventilation: a novel treatment for sleep apnea associated with use of opioids. J Clin Sleep Med. 2008 Aug 15;4(4):305-10.
PubMed 18763420Oldenburg O, Spiesshofer J, Fox H, Prib N, Horstkotte D. Performance of conventional and enhanced adaptive servoventilation (ASV) in heart failure patients with central sleep apnea who have adapted to conventional ASV. Sleep Breath. 2015 Sep;19(3):795-800. doi: 10.1007/s11325-014-1083-9. Epub 2014 Nov 21.
PubMed 25413958
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Modified Adaptive Servoventilation Therapy With Conventional Adaptive Servoventilation Therapy in Patients With Periodic Breathing
- ClinicalTrials.gov ID
- NCT01405313
- Acronym / sponsor ID
- MA231210
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Posted 20 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine if modified adaptive servoventilation (ASV) is as effective as the conventional ASV in treating periodic breathing. The study will determine if the modified ASV reacts appropriately to reduce apneas and hypopneas and provides suitable levels of positive airway pressure compared to conventional ASV.
Detailed description
Adaptive servoventilation (ASV) is a type of non-invasive ventilation which ameliorates central sleep and/or mixed apnea and periodic breathing. Previous studies in the field have shown that treatment of periodic breathing with ASV improves sleep quality and quality of life. In reducing central apneas, ASV reduces overall arousal index, and increases overall slow wave sleep and rapid eye movement (REM) sleep more than oxygen, continuous positive airway pressure or bi-level treatments. ASV can also more effectively reduce central apnea and overall apnea/hypopnea index (AHI) in patients on long-term opiates, and appears to effectively treat Complex Sleep Apnea Syndrome. It is more effective than other forms of non-invasive ventilation for patients with central and/or mixed apnea or periodic breathing, and is better tolerated.
This is a prospective, randomised, crossover, observational study. Subjects will spend one night on conventional ASV and one night on modified ASV with full in-lab polysomnography (PSG) during therapy on both nights.
Objective and subjective parameters will be recorded and analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified ASV | Experimental | Device: Modified Adaptive Servoventilation DeviceModified ASV Enhanced ASV algorithm which includes auto-adjusting expiratory pressure. |
| Conventional ASV | Active comparator | Device: Conventional Adaptive Servoventilation deviceConventional ASV This is the current (predicate) ASV algorithm. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21+ years old
- Chronic ResMed ASV therapy patient
- Current ASV therapy for at least 4 weeks
- Able to understand fully the study information and participation requirements
- Provide signed informed consent
Key exclusion criteria (10 listed)
- Acute cardiac decompensation
- Acute myocardial infarction within last 3 months
- Resuscitation within last 3 months
- Stroke with swallowing disorders or persistent hemiparesis
- Blood pressure test at end expiratory pressure (EEP) 10cmH2O not passed
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 |
|---|---|---|
| Modified Adaptive Servoventilation DeviceAlso: ResMed Enhanced ASV, ASVAutoThe modified ASV has a greater adaptive response to meet a target ventilation level that is constantly being assessed. | Device | Modified ASV |
| Conventional Adaptive Servoventilation deviceAlso: ResMed AutoSet CS2, ResMed VPAP Adapt SV, ResMed S9 VPAP AdaptPressure support ventilation adapts to meet a target ventilation level that is constantly being assessed. | Device | Conventional ASV |
Primary outcome
Apnea/Hypopnea Index (AHI)
Time frame: One night
Physiological sleep signals including pulse oximetry (SpO2), respiratory effort and nasal flow, will be recorded, analysed and reported in the form of an index per hour of sleep. Apnea-Hypopnea Index is calculated counting all apneas (reduction of respiratory flow by >90% for at least 10 seconds) plus all hypopneas (reduction of respiratory flow by >30% for at least 10 seconds with a 4% SpO2 reduction) divided by hours of sleep.
1 secondary outcome
Oxygen Desaturation Index (ODI)
Time frame: One night
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11520725Teschler H, Dohring J, Wang YM, Berthon-Jones M. Adaptive pressure support servo-ventilation: a novel treatment for Cheyne-Stokes respiration in heart failure. Am J Respir Crit Care Med. 2001 Aug 15;164(4):614-9. doi: 10.1164/ajrccm.164.4.9908114.
- Background: PubMed 12928310Pepperell JC, Maskell NA, Jones DR, Langford-Wiley BA, Crosthwaite N, Stradling JR, Davies RJ. A randomized controlled trial of adaptive ventilation for Cheyne-Stokes breathing in heart failure. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1109-14. doi: 10.1164/rccm.200212-1476OC. Epub 2003 Aug 19.
- Background: PubMed 15252739Schadlich S, Konigs I, Kalbitz F, Blankenburg T, Busse HJ, Schutte W. [Cardiac efficiency in patients with Cheyne-Stokes respiration as a result of heart insufficiency during long-term nasal respiratory treatment with adaptive servo ventilation (AutoSet CS)]. Z Kardiol. 2004 Jun;93(6):454-62. doi: 10.1007/s00392-004-0083-3. German.
- Background: PubMed 18486550Oldenburg O, Schmidt A, Lamp B, Bitter T, Muntean BG, Langer C, Horstkotte D. Adaptive servoventilation improves cardiac function in patients with chronic heart failure and Cheyne-Stokes respiration. Eur J Heart Fail. 2008 Jun;10(6):581-6. doi: 10.1016/j.ejheart.2008.04.007. Epub 2008 May 16.
- Background: PubMed 18763420Javaheri S, Malik A, Smith J, Chung E. Adaptive pressure support servoventilation: a novel treatment for sleep apnea associated with use of opioids. J Clin Sleep Med. 2008 Aug 15;4(4):305-10.
- Results publication: PubMed 25413958Oldenburg O, Spiesshofer J, Fox H, Prib N, Horstkotte D. Performance of conventional and enhanced adaptive servoventilation (ASV) in heart failure patients with central sleep apnea who have adapted to conventional ASV. Sleep Breath. 2015 Sep;19(3):795-800. doi: 10.1007/s11325-014-1083-9. Epub 2014 Nov 21.
- 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.
Olaf Oldenburg, MD principal investigator
Heart and Diabetes Centre, Ruhr University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Adaptive Servoventilation Device and Conventional Adaptive Servoventilation device in people with Periodic Breathing and Breathing-Related Sleep Disorder, run by ResMed at 1 site in Germany.
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 10 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 20 Mar 2017. 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 Germany. 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 20 Mar 2017). 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: One night). 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 NCT01405313, which also lists 6 linked publications.
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 20 Mar 2017.