Periodic BreathingNCT01037439
Comparison of Modified With Conventional Adaptive Servoventilation Processes
A study of Periodic Breathing and Cheyne-Stokes Respiration, run by ResMed at 1 site in Germany.
Trial summary
The objective of this study is to compare the modified adaptive servoventilation control algorithm of the with the standardised algorithms of routinely-used servoventilation processes (AutoSet CS2) in terms of the effect on obstructive and central events. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periodic Breathing, Cheyne-Stokes Respiration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ years of age
- consent in writing
- complex nocturnal breathing disorder with Cheyne-Stokes breathing and obstructive sleep apnoea
- AHI > 15/h
Who cannot join
- acute cardiac decompensation
- acute myocardial infarct within the last 3 months
- post-resuscitation condition within the last 3 months
- post-stroke condition with difficulty in swallowing or persisting hemiparesis
- abuse of medication, alcohol or drugs
- pregnancy
- known to be suffering from a tumour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Modified Adaptive Servoventilation With Conventional Adaptive Servoventilation Processes in Terms of Efficacy Against Complex Nocturnal Breathing Disorders
The objective of this study is to compare the modified adaptive servoventilation control algorithm of the with the standardised algorithms of routinely-used servoventilation processes (AutoSet CS2) in terms of the effect on obstructive and central events. The aim is to normalise breathing during sleep and hence eliminate the sleep-related breathing disorder, resulting in even more effective treatment of nocturnal breathing disorders in patients with cardiovascular diseases and sleep apnoea, to ensure optimum therapy success.
Read the detailed description
Patients with cardiovascular disorders frequently suffer from sleep-related respiratory disorders (SRRD), such as obstructive sleep apnea (OSA) or a specific form of central sleep apnea, Cheyne-Stokes breathing (CSB, periodic breathing). However there is also a significant incidence of complex nocturnal breathing disorders, with both obstructive and central components. Sleep-related breathing disorders of this kind cause decreases in arterial oxygen saturation through brief hypopneas and apneas. Disturbed breathing also causes the patient to wake frequently during the night (arousals), usually during the hyperventilatory phase of CSB. Repeated arousals cause fragmentation of sleep, and therefore a deep sleep deficit. This leads to increased sleepiness during the day and impaired cognitive performance.
Previous studies have shown that Cheyne-Stokes breathing can be treated effectively with adaptive servoventilation. An enhancement to the routinely used algorithm (AutoSet CS2) has been created which allows the algorithm to differentiate between obstructive events and Cheyne-Stokes breathing, and better respond to apneas and hypopneas to eliminate the sleep-related breathing disorder and normalise breathing during sleep.
- Conditions
- Periodic Breathing, Cheyne-Stokes Respiration
- Being tested
- Adaptive Servo-controlled Ventilation (ASV)
- Medical subject headings
- Cheyne-Stokes Respiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Servo-controlled Ventilation (ASV)Device
Also called AutoSet CS2, Adapt SV
Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed
| Study group | Role | What they receive |
|---|---|---|
| Conventional ASV | Active comparator | Current adaptive servoventilation therapy algorithm for non invasive ventilation treatment of Cheyne-Stokes Respiration. Receives: Device: Adaptive Servo-controlled Ventilation (ASV) |
| Modified ASV | Experimental | Modified adaptive servoventilation algorithm for improved treatment of nocturnal breathing disorders Receives: Device: Adaptive Servo-controlled Ventilation (ASV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/hypopnea index (AHI)
number of breathing pauses that occur each hour of sleep
Measured: 1 night sleep
Secondary outcomes (4)
Average SaO2
average percentage of oxygen saturation in the blood
Measured: 1 night sleep
CPAP pressure
Continuous Positive Airway Pressure requirement for elimination of nocturnal breathing disorders
Measured: 1 night sleep
Pressure stability in presence of mask leaks
How much the CPAP pressure varies when mask leak occurs
Measured: 1 night sleep
Minimum SaO2
The minimum percentage of oxygen saturation recorded in the blood
Measured: 1 night sleep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helmut Teschler, MD, Principal investigator, University Hospital, Ruhrland Hospital Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037439
- Sponsor's protocol ID
- MAEssenASV
- Status last verified
- Feb 2021
- First submitted
- 21 Dec 2009
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Modified Adaptive Servoventilation With Conventional Adaptive Servoventilation Processes in Terms of Efficacy Against Complex Nocturnal Breathing Disorders
- ClinicalTrials.gov ID
- NCT01037439
- Acronym / sponsor ID
- MAEssenASV
- Conditions
- Periodic Breathing, Cheyne-Stokes Respiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the modified adaptive servoventilation control algorithm of the with the standardised algorithms of routinely-used servoventilation processes (AutoSet CS2) in terms of the effect on obstructive and central events. The aim is to normalise breathing during sleep and hence eliminate the sleep-related breathing disorder, resulting in even more effective treatment of nocturnal breathing disorders in patients with cardiovascular diseases and sleep apnoea, to ensure optimum therapy success.
Detailed description
Patients with cardiovascular disorders frequently suffer from sleep-related respiratory disorders (SRRD), such as obstructive sleep apnea (OSA) or a specific form of central sleep apnea, Cheyne-Stokes breathing (CSB, periodic breathing). However there is also a significant incidence of complex nocturnal breathing disorders, with both obstructive and central components. Sleep-related breathing disorders of this kind cause decreases in arterial oxygen saturation through brief hypopneas and apneas. Disturbed breathing also causes the patient to wake frequently during the night (arousals), usually during the hyperventilatory phase of CSB. Repeated arousals cause fragmentation of sleep, and therefore a deep sleep deficit. This leads to increased sleepiness during the day and impaired cognitive performance.
Previous studies have shown that Cheyne-Stokes breathing can be treated effectively with adaptive servoventilation. An enhancement to the routinely used algorithm (AutoSet CS2) has been created which allows the algorithm to differentiate between obstructive events and Cheyne-Stokes breathing, and better respond to apneas and hypopneas to eliminate the sleep-related breathing disorder and normalise breathing during sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional ASV | Active comparator | Device: Adaptive Servo-controlled Ventilation (ASV)Current adaptive servoventilation therapy algorithm for non invasive ventilation treatment of Cheyne-Stokes Respiration. |
| Modified ASV | Experimental | Device: Adaptive Servo-controlled Ventilation (ASV)Modified adaptive servoventilation algorithm for improved treatment of nocturnal breathing disorders |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18+ years of age
- consent in writing
- complex nocturnal breathing disorder with Cheyne-Stokes breathing and obstructive sleep apnoea
- AHI > 15/h
Key exclusion criteria (7 listed)
- acute cardiac decompensation
- acute myocardial infarct within the last 3 months
- post-resuscitation condition within the last 3 months
- post-stroke condition with difficulty in swallowing or persisting hemiparesis
- abuse of medication, alcohol or drugs
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 |
|---|---|---|
| Adaptive Servo-controlled Ventilation (ASV)Also: AutoSet CS2, Adapt SVPressure support ventilation adapts to meet a target ventilation level that is constantly being assessed | Device | Conventional ASV, Modified ASV |
Primary outcome
Apnea/hypopnea index (AHI)
Time frame: 1 night sleep
number of breathing pauses that occur each hour of sleep
4 secondary outcomes
Average SaO2
Time frame: 1 night sleep
CPAP pressure
Time frame: 1 night sleep
Pressure stability in presence of mask leaks
Time frame: 1 night sleep
Minimum SaO2
Time frame: 1 night sleep
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
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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.
Helmut Teschler, MD principal investigator
University Hospital, Ruhrland Hospital Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Periodic Breathing and Cheyne-Stokes Respiration, 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 4 inclusion and 7 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 5 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 1 night sleep). 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 5 Feb 2021.