Heart DiseasesVCRNCT00811668
Comparison of CPAP With SOMNOventCR in Patients With Underlying Heart Disease, Combined OSA and CSR
A study testing CPAP before SOMNOVentCR and SOMNOventCR before CPAP in people with Heart Diseases and Sleep Apnea, Central, run by Wissenschaftliches Institut Bethanien e.V.
Trial summary
In patients with underlying heart diseases like hypertensive heart disease, coronary heart disease or dilative cardiomyopathy obstructive sleep-apnea, central sleep-apnea and Cheyne-Stokes-respiration are common finding in polysomnography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases, Sleep Apnea, Central, Sleep Apnea, Obstructive
- What is being tested?
- CPAP before SOMNOVentCR and SOMNOventCR before CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women > 18 years.
- Diagnosis of arterial hypertension or a coronary heart disease or a dilative cardiomyopathy
- Combined sleep-apnea-syndrome with a total value of AHI>15 per hour and a rate up to 20% of central events or periodic breathing.
Who cannot join
- Heart failure NYHA-CLASS IV.
- Myocardial infarction or unstable angina pectoris or cardiac surgery within the last three months.
- Apnea-hypopnea-index < 15 per hour.
- Obstructive breathing disturbances up to 80%.
- Pregnancy.
- Absence of declaration of consent.
Show all 9Show fewer
- Malign diseases.
- Serious (Severe) chronic oxygen-requiring pulmonary illness.
- Age under 18 years.
About this study
Official title: Crossover Comparison of Treatment With Continuous Positive Airway Pressure and Treatment With Adaptive Servo Ventilation (SOMNOventCR) in Patients With Underlying Heart Disease, Combined Obstructive Sleep Apnea and Cheyne-Stokes Respiration.
In patients with underlying heart diseases like hypertensive heart disease, coronary heart disease or dilative cardiomyopathy obstructive sleep-apnea, central sleep-apnea and Cheyne-Stokes-respiration are common finding in polysomnography.
In a lot of these patients it is neither a purely obstructive sleep-apnea syndrome nor a complete Cheyne-Stokes-respiration but a combination of both sleep related respiratory disturbances.
Read more
Previous studies showed an improvement of the central respiratory disorder, for example Cheyne-Stokes-respiration, under continuous positive pressure breathing (CPAP) and an improvement of the left ventricular pump function. (Naughton 1995, Tkacova 1997).
However, the recently published CanPAP study could not prove any improvement in the mortality among CPAP therapy patients in comparison to the optimal medical treatment, although under this therapy, the number of breathing disturbances, the oxygen saturation at night and the ejection fraction of the left ventricle showed a significant improvement.(Bradley 2005)
Earlier studies proved the adaptive servo ventilation to be an effective therapy for patients with central sleep-apnea and Cheyne-Stokes-respiration respectively. (Teschler 2001) Teschler's study showed that the adaptive servo ventilation therapy with a reduction of central sleep apnea down to 10/hours succeeded. With the SOMNOvent CR a new therapy-algorithm has been developed for the adaptive servo ventilation in patients with obstructive sleep apnea and Cheyne-Stokes-respiration with underlying heart disease. In the first validation study this therapy was very effective and presented only few adverse effects in the patients. (Galetke 2007)
The goal of the study was to compare this new therapeutic option (SOMNOvent CR) with the established method of continuous positive airway pressure (CPAP) in patients with combination of obstructive sleep-apnea syndrome and Cheyne-Stokes-respiration with underlying heart disease.
Read the detailed description
Patients who meet all the above mentioned criteria and who were diagnosed as sleep-apnoea syndrome patients in our hospital were asked to participate in the study.
We divided the patients in two groups:
Group 1: started with CPAP and continued with SOMNOvent CR Group 2: began with SOMNOvent CR and ended with CPAP
First of all a CPAP-titration was applied to both fixed groups during the second night. During the third night they received either the CPAP- pressure (first group) or the adaptive servo ventilation (second group. The patients were discharged from the hospital continuing with the procedure of the third night.
After four weeks a new admission for the sleep laboratory was necessary and, during the first night, a control investigation with the procedure of the last four weeks. The procedure changed during the next night, so that the patients of the first group now slept with the SOMNOventCR-device and the patients of the second group with the CPAP-device.
After a wash-out-period of a week and a four-week treatment with the last procedure a final in-hospital polysomnography was performed in which adaptive servo ventilation was applied to the first group and fixed CPAP to the second group.
After the study ended, the patients received the therapy procedure which was the most effective and which was better tolerated.
The following analyses were carried out in addition to the polysomnographic measurements:
Admission 1: Berlin questionnaire, European sleep questionnaire, echocardiography, 6 minute walking test, patients questionnaire.
Admission 2: ESS, Berlin questionnaire, echocardiography, 6 minute walking test, patients´ questionnaire.
After the wash-out-period: ESS, Berlin questionnaire, patients questionnaire.
Admission 4: ESS, Berlin questionnaire, echocardiography, 6 minute walking test, patients questionnaire.
- Being tested
- CPAP before SOMNOVentCR, SOMNOventCR before CPAP
- Keywords
- Sleep Apnea Syndromes, heart diseases
- Medical subject headings
- Heart Diseases, Sleep Apnea, Central, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP before SOMNOVentCRDevice
4 weeks CPAP treatment, 1 week wash out period, 4 weeks SOMNOventCR treatment
SOMNOventCR before CPAPDevice
4 weeks SOMNOventCR treatment, 1 week wash out period, 4 weeks CPAP treatment
| Study group | Role | What they receive |
|---|---|---|
| CPAP before SOMNOVentCR | Experimental | started with CPAP and continued with SOMNOvent CR Receives: Device: CPAP before SOMNOVentCR |
| SOMNOVentCR before CPAP | Experimental | began with SOMNOvent CR and ended with CPAP Receives: Device: SOMNOventCR before CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
central apnea-hypopnea-index
Measured: February 2009
Secondary outcomes (1)
Total apnea-hypopnea-index, minimum and mean oxygen saturation, compliance, subjective satisfaction with the therapy (questionnaire), left ventricular ejection fraction , six minutes walking distances.
Measured: February 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startMay 2008
- Primary completionFeb 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies 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
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolfgang Galetke, PD Dr., Study chairWinfried J. Randerath, Prof. Dr., Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811668
- Sponsor's protocol ID
- WI_VentCR_13/2008
- Acronym
- VCR
- Status last verified
- Aug 2011
- First submitted
- 18 Dec 2008
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Bradley TD, Logan AG, Kimoff RJ, Series F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Tomlinson G, Floras JS; CANPAP Investigators. Continuous positive airway pressure for central sleep apnea and heart failure. N Engl J Med. 2005 Nov 10;353(19):2025-33. doi: 10.1056/NEJMoa051001.
PubMed 16282177Naughton MT, Liu PP, Bernard DC, Goldstein RS, Bradley TD. Treatment of congestive heart failure and Cheyne-Stokes respiration during sleep by continuous positive airway pressure. Am J Respir Crit Care Med. 1995 Jan;151(1):92-7. doi: 10.1164/ajrccm.151.1.7812579.
PubMed 7812579Teschler 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 11520725Tkacova R, Hall MJ, Liu PP, Fitzgerald FS, Bradley TD. Left ventricular volume in patients with heart failure and Cheyne-Stokes respiration during sleep. Am J Respir Crit Care Med. 1997 Nov;156(5):1549-55. doi: 10.1164/ajrccm.156.5.9612101.
PubMed 9372674Javaheri S, Parker TJ, Liming JD, Corbett WS, Nishiyama H, Wexler L, Roselle GA. Sleep apnea in 81 ambulatory male patients with stable heart failure. Types and their prevalences, consequences, and presentations. Circulation. 1998 Jun 2;97(21):2154-9. doi: 10.1161/01.cir.97.21.2154.
PubMed 9626176
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover Comparison of Treatment With Continuous Positive Airway Pressure and Treatment With Adaptive Servo Ventilation (SOMNOventCR) in Patients With Underlying Heart Disease, Combined Obstructive Sleep Apnea and Cheyne-Stokes Respiration.
- ClinicalTrials.gov ID
- NCT00811668
- Acronym / sponsor ID
- VCR / WI_VentCR_13/2008
- Keywords
- Sleep Apnea Syndromes, heart diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Dec 2008 (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.
In patients with underlying heart diseases like hypertensive heart disease, coronary heart disease or dilative cardiomyopathy obstructive sleep-apnea, central sleep-apnea and Cheyne-Stokes-respiration are common finding in polysomnography.
In a lot of these patients it is neither a purely obstructive sleep-apnea syndrome nor a complete Cheyne-Stokes-respiration but a combination of both sleep related respiratory disturbances.
Previous studies showed an improvement of the central respiratory disorder, for example Cheyne-Stokes-respiration, under continuous positive pressure breathing (CPAP) and an improvement of the left ventricular pump function. (Naughton 1995, Tkacova 1997).
However, the recently published CanPAP study could not prove any improvement in the mortality among CPAP therapy patients in comparison to the optimal medical treatment, although under this therapy, the number of breathing disturbances, the oxygen saturation at night and the ejection fraction of the left ventricle showed a significant improvement.(Bradley 2005)
Earlier studies proved the adaptive servo ventilation to be an effective therapy for patients with central sleep-apnea and Cheyne-Stokes-respiration respectively. (Teschler 2001) Teschler's study showed that the adaptive servo ventilation therapy with a reduction of central sleep apnea down to 10/hours succeeded. With the SOMNOvent CR a new therapy-algorithm has been developed for the adaptive servo ventilation in patients with obstructive sleep apnea and Cheyne-Stokes-respiration with underlying heart disease. In the first validation study this therapy was very effective and presented only few adverse effects in the patients. (Galetke 2007)
The goal of the study was to compare this new therapeutic option (SOMNOvent CR) with the established method of continuous positive airway pressure (CPAP) in patients with combination of obstructive sleep-apnea syndrome and Cheyne-Stokes-respiration with underlying heart disease.
Detailed description
Patients who meet all the above mentioned criteria and who were diagnosed as sleep-apnoea syndrome patients in our hospital were asked to participate in the study.
We divided the patients in two groups:
Group 1: started with CPAP and continued with SOMNOvent CR Group 2: began with SOMNOvent CR and ended with CPAP
First of all a CPAP-titration was applied to both fixed groups during the second night. During the third night they received either the CPAP- pressure (first group) or the adaptive servo ventilation (second group. The patients were discharged from the hospital continuing with the procedure of the third night.
After four weeks a new admission for the sleep laboratory was necessary and, during the first night, a control investigation with the procedure of the last four weeks. The procedure changed during the next night, so that the patients of the first group now slept with the SOMNOventCR-device and the patients of the second group with the CPAP-device.
After a wash-out-period of a week and a four-week treatment with the last procedure a final in-hospital polysomnography was performed in which adaptive servo ventilation was applied to the first group and fixed CPAP to the second group.
After the study ended, the patients received the therapy procedure which was the most effective and which was better tolerated.
The following analyses were carried out in addition to the polysomnographic measurements:
Admission 1: Berlin questionnaire, European sleep questionnaire, echocardiography, 6 minute walking test, patients questionnaire.
Admission 2: ESS, Berlin questionnaire, echocardiography, 6 minute walking test, patients´ questionnaire.
After the wash-out-period: ESS, Berlin questionnaire, patients questionnaire.
Admission 4: ESS, Berlin questionnaire, echocardiography, 6 minute walking test, patients questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP before SOMNOVentCR | Experimental | Device: CPAP before SOMNOVentCRstarted with CPAP and continued with SOMNOvent CR |
| SOMNOVentCR before CPAP | Experimental | Device: SOMNOventCR before CPAPbegan with SOMNOvent CR and ended with CPAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women > 18 years.
- Diagnosis of arterial hypertension or a coronary heart disease or a dilative cardiomyopathy
- Combined sleep-apnea-syndrome with a total value of AHI>15 per hour and a rate up to 20% of central events or periodic breathing.
Key exclusion criteria (9 listed)
- Heart failure NYHA-CLASS IV.
- Myocardial infarction or unstable angina pectoris or cardiac surgery within the last three months.
- Apnea-hypopnea-index < 15 per hour.
- Obstructive breathing disturbances up to 80%.
- Pregnancy.
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 |
|---|---|---|
| CPAP before SOMNOVentCR4 weeks CPAP treatment, 1 week wash out period, 4 weeks SOMNOventCR treatment | Device | CPAP before SOMNOVentCR |
| SOMNOventCR before CPAP4 weeks SOMNOventCR treatment, 1 week wash out period, 4 weeks CPAP treatment | Device | SOMNOVentCR before CPAP |
Primary outcome
central apnea-hypopnea-index
Time frame: February 2009
1 secondary outcome
Total apnea-hypopnea-index, minimum and mean oxygen saturation, compliance, subjective satisfaction with the therapy (questionnaire), left ventricular ejection fraction , six minutes walking distances.
Time frame: February 2009
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 21 Dec 2023.
- Background: PubMed 16282177Bradley TD, Logan AG, Kimoff RJ, Series F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Tomlinson G, Floras JS; CANPAP Investigators. Continuous positive airway pressure for central sleep apnea and heart failure. N Engl J Med. 2005 Nov 10;353(19):2025-33. doi: 10.1056/NEJMoa051001.
- Background: PubMed 7812579Naughton MT, Liu PP, Bernard DC, Goldstein RS, Bradley TD. Treatment of congestive heart failure and Cheyne-Stokes respiration during sleep by continuous positive airway pressure. Am J Respir Crit Care Med. 1995 Jan;151(1):92-7. doi: 10.1164/ajrccm.151.1.7812579.
- 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 9372674Tkacova R, Hall MJ, Liu PP, Fitzgerald FS, Bradley TD. Left ventricular volume in patients with heart failure and Cheyne-Stokes respiration during sleep. Am J Respir Crit Care Med. 1997 Nov;156(5):1549-55. doi: 10.1164/ajrccm.156.5.9612101.
- Background: PubMed 9626176Javaheri S, Parker TJ, Liming JD, Corbett WS, Nishiyama H, Wexler L, Roselle GA. Sleep apnea in 81 ambulatory male patients with stable heart failure. Types and their prevalences, consequences, and presentations. Circulation. 1998 Jun 2;97(21):2154-9. doi: 10.1161/01.cir.97.21.2154.
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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.
Wolfgang Galetke, PD Dr. study chair
Winfried J. Randerath, Prof. Dr. study director
Questions about this trial
What is this clinical trial studying?
A study testing CPAP before SOMNOVentCR and SOMNOventCR before CPAP in people with Heart Diseases and Sleep Apnea, Central, run by Wissenschaftliches Institut Bethanien e.V.
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 3 inclusion and 9 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 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
central apnea-hypopnea-index (time frame: February 2009). 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 NCT00811668, which also lists 5 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 21 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.