Complex Sleep ApneaCSA-FKKGNCT01609244
Bilevel Versus Servoventilation in Complex Sleep Apnea
A study testing Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany) and servoventilation (Somnovent CR, Weinmann, Hamburg, Germany) in people with Complex Sleep Apnea and CPAP Induced Central Sleep Apnea, run by Krankenhaus Kloster Grafschaft at 1 site in Germany.
Trial summary
Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with complex sleep apnea during continuous positive airway pressure (CPAP) treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complex Sleep Apnea, CPAP Induced Central Sleep Apnea
- What is being tested?
- Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany) and servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Jul 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment
Who cannot join
- primary central sleep apnea non-compliance to CPAP therapy
Trial locations and contacts
1 site in 1 country.
About this study
Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with complex sleep apnea during continuous positive airway pressure (CPAP) treatment.
Read the detailed description
Patients with primary obstructive sleep apnea, who develop complex sleep apnea after CPAP treatment of 4-6 weeks duration were randomized to either receive Bilevel of Servoventilation treatment. Parameters of sleep as well as apnea-hypopnea indices are to be compared.
- Being tested
- Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany), servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)
- Keywords
- Sleep apnea, central sleep apnea, bilevel, servoventilation, CPAP
- 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.
Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)Device
nighttime positive airway therapy for 6 weeks
servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)Device
nighttime positive airway therapy for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bilevel | Active comparator | Bilevel therapy Receives: Device: Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany) |
| Servoventilation | Active comparator | servoventilation therapy Receives: Device: servoventilation (Somnovent CR, Weinmann, Hamburg, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea-hypopnea index
apneas and hypopneas under therapy
Measured: at 6 weeks
Secondary outcomes (1)
Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy
parameters of sleep quality
Measured: at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startJan 2010
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complex Sleep ApneaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Kloster Grafschaft
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominic Dellweg, M.D., Krankenhaus Kloster Grafschaft
- Investigators
- Dominic Dellweg, MD, Study chair, FKKG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609244
- Sponsor's protocol ID
- CSA-2010
- Acronym
- CSA-FKKG
- Status last verified
- Jan 2016
- First submitted
- 25 May 2012
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuzniar TJ, Pusalavidyasagar S, Gay PC, Morgenthaler TI. Natural course of complex sleep apnea--a retrospective study. Sleep Breath. 2008 May;12(2):135-9. doi: 10.1007/s11325-007-0140-z.
PubMed 17874254Dellweg D, Kerl J, Hoehn E, Wenzel M, Koehler D. Randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus servoventilation in patients with CPAP-induced central sleep apnea (complex sleep apnea). Sleep. 2013 Aug 1;36(8):1163-71. doi: 10.5665/sleep.2878.
PubMed 23904676
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilevel Versus Servoventilation in Complex Sleep Apnea
- ClinicalTrials.gov ID
- NCT01609244
- Acronym / sponsor ID
- CSA-FKKG / CSA-2010
- Keywords
- Sleep apnea, central sleep apnea, bilevel, servoventilation, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Krankenhaus Kloster GrafschaftUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 31 May 2012 (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.
Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with complex sleep apnea during continuous positive airway pressure (CPAP) treatment.
Detailed description
Patients with primary obstructive sleep apnea, who develop complex sleep apnea after CPAP treatment of 4-6 weeks duration were randomized to either receive Bilevel of Servoventilation treatment. Parameters of sleep as well as apnea-hypopnea indices are to be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilevel | Active comparator | Device: Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)Bilevel therapy |
| Servoventilation | Active comparator | Device: servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)servoventilation therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment
Key exclusion criteria (1 listed)
- primary central sleep apnea non-compliance to CPAP therapy
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 |
|---|---|---|
| Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)nighttime positive airway therapy for 6 weeks | Device | Bilevel |
| servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)nighttime positive airway therapy for 6 weeks | Device | Servoventilation |
Primary outcome
apnea-hypopnea index
Time frame: at 6 weeks
apneas and hypopneas under therapy
1 secondary outcome
Percentage slow wave sleep, percentage rapid eye movement (REM) sleep, Arousal index, sleep time, sleep efficacy
Time frame: at 6 weeks
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 8 Jan 2016.
- Background: PubMed 17874254Kuzniar TJ, Pusalavidyasagar S, Gay PC, Morgenthaler TI. Natural course of complex sleep apnea--a retrospective study. Sleep Breath. 2008 May;12(2):135-9. doi: 10.1007/s11325-007-0140-z.
- Derived from this study: PubMed 23904676Dellweg D, Kerl J, Hoehn E, Wenzel M, Koehler D. Randomized controlled trial of noninvasive positive pressure ventilation (NPPV) versus servoventilation in patients with CPAP-induced central sleep apnea (complex sleep apnea). Sleep. 2013 Aug 1;36(8):1163-71. doi: 10.5665/sleep.2878.
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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.
Dominic Dellweg, MD study chair
FKKG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany) and servoventilation (Somnovent CR, Weinmann, Hamburg, Germany) in people with Complex Sleep Apnea and CPAP Induced Central Sleep Apnea, run by Krankenhaus Kloster Grafschaft 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 1 inclusion and 1 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 8 Jan 2016. 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 (time frame: at 6 weeks). 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 NCT01609244, which also lists 2 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 8 Jan 2016.