Long-term comparison of BiPAP® autoSV™ versus continuous positive airway pressure in patients with mixed sleep apnoea syndrome and underlying cardiovascular diseases (Vergleich der behandlung mit kontinuierlicher konstanter psotivdruckatmung [CPAP] und der beatmung mit adaptiver servovventilation mit dem gerat BiPAP® autoSV™ bei patienten mit cheyne-stokes-atmung)
ISRCTN | ISRCTN70594408 |
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DOI | https://doi.org/10.1186/ISRCTN70594408 |
Secondary identifying numbers | Rand001 |
- Submission date
- 16/04/2007
- Registration date
- 16/05/2007
- Last edited
- 11/12/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Winfried Randerath
Scientific
Scientific
Wissenschaftliches Institut Bethanien e.V.
Aufderhoherstrasse 169
Solingen
42699
Germany
Study information
Study design | Randomised controlled double blind trial of BiPAP® autoSV™ therapy versus CPAP |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | BiPAP® autoSV™ is superior to Continuous Positive Airway Pressure (CPAP) in reducing breathing disturbances during sleep and improving cardiac function. |
Ethics approval(s) | Approved by the local ethics committee (Universitat Witten/Herdecke Ethik-Kommission) on the 4th September 2006. |
Health condition(s) or problem(s) studied | Sleep disordered breathing and cardiovascular disease. |
Intervention | Control: Nasal Continuous Positive Airway Pressure (CPAP) is the current gold standard treatment for Obstructive Sleep Apnoea Syndrome. CPAP can crudely be described as a small air pump attached to a mask that is worn over the nose and pumps a fixed amount of pressurised air through the nares to prevent upper airway collapse whilst sleeping. Intervention: Adaptive Servo-Ventilation machines (ASV) provide Expiratory Positive Airway Pressure (EPAP) or CPAP support to sustain upper-airway patency as with a CPAP machine but also modulate the Inspiratory Positive Airway Pressure (IPAP) in response to central and cheyne-stokes events. After a baseline polysomnography (first night) patients are randomly assigned to either CPAP or BiPAP® autoSV™. They will then undergo two titration nights on therapy. After the first titration night the patients are asked for side-effects using a standardised questionnaire. On the fourth night the titrated values are validated. The CPAP level should be set to greater than or equal to 10 mbar. After 3 months and 12 months the patients are re-evaluated polysomographically and have outcomes measured. The devices are also read out for treatment compliance. After six months and nine months the patients are contacted by telephone to find out any problems with mask, device or compliance. |
Intervention type | Other |
Primary outcome measure | Central AHI, measured at baseline, 3 and 12 months. |
Secondary outcome measures | 1. Total AHI, measured at baseline, 3 and 12 months 2. Maximal oxygen uptake (VO2 max), measured at baseline, 3 and 12 months 3. Left ventricular ejection fraction (echocardiography), measured at baseline, 3 and 12 months 4. Minimal and mean oxygen saturation (polysomnography), measured at baseline, 3 and 12 months 5. Compliance, measured at 3 and 12 months only 6. Quality of life (Minnesota questionnaire), measured at baseline, 3 and 12 months 7. Brain Natriuretic Peptide (BNP) level, measured at baseline, 3 and 12 months 8. Mortality, measured at 3 and 12 months only 9. Rate of cardiovascular complications, for example hospital admissions are examined for twelve months, measured at 3 and 12 months only |
Overall study start date | 01/01/2007 |
Completion date | 01/07/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 70 |
Key inclusion criteria | 1. Men and women 18 years of age and older 2. Arterial hypertension, ischaemic heart disease, idiopathic dilated cardiomyopathy with heart failure functional class New York Heart Association (NYHA) II and III and left ventricular ejection fraction greater than 20% (echocardiography) 3. Mixed sleep apnoea syndrome with an Apnoea Hypopnoea Index (AHI) greater than or equal to 15/hour with a proportion of central/periodic disturbances of less than 80% and a proportion of obstructive disturbances of between 20 and 50% 4. Medical treatment of their underlying heart disease has been optimised |
Key exclusion criteria | 1. Heart failure functional class NYHA IV 2. Myocardial infarction, unstable angina or cardiac surgery within the previous three months, obstructive disturbances of 50% or greater 3. Pregnancy 4. Patients with pure Cheyne-Stokes Respiration (CSR)/Central Sleep Apnoea (CSA) (greater than 80% of disturbances), patients with greater than 50% obstructive disturbances |
Date of first enrolment | 01/01/2007 |
Date of final enrolment | 01/07/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Wissenschaftliches Institut Bethanien e.V.
Solingen
42699
Germany
42699
Germany
Sponsor information
Respironics International, Inc (France)
Industry
Industry
Immeuble Hermès
20, rue Jacques Daguerre
Rueil Malmaison
Paris
92565
France
Website | http://www.respironics.com |
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https://ror.org/05jz46060 |
Funders
Funder type
Industry
Respironics International, Inc (France)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/08/2012 | Yes | No |