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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
DOI 10.1186/ISRCTN70594408
ClinicalTrials.gov identifier
EudraCT number
Public title 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)
Scientific title
Acronym N/A
Serial number at source Rand001
Study hypothesis BiPAP® autoSV™ is superior to Continuous Positive Airway Pressure (CPAP) in reducing breathing disturbances during sleep and improving cardiac function.
Lay summary Not provided at time of registration
Ethics approval Approved by the local ethics committee (Universitat Witten/Herdecke Ethik-Kommission) on the 4th September 2006.
Study design Randomised controlled double blind trial of BiPAP® autoSV™ therapy versus CPAP
Countries of recruitment Germany
Disease/condition/study domain Sleep disordered breathing and cardiovascular disease.
Participants - 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
Participants - 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
Anticipated start date 01/01/2007
Anticipated end date 01/07/2008
Status of trial Completed
Patient information material
Target number of participants 70
Interventions 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.
Primary outcome measure(s) Central AHI, measured at baseline, 3 and 12 months.
Secondary outcome measure(s) 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
Sources of funding Respironics International, Inc (France)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22281801
Contact name Prof  Winfried  Randerath
  Address Wissenschaftliches Institut Bethanien e.V.
Aufderhoherstrasse 169
  City/town Solingen
  Zip/Postcode 42699
  Country Germany
Sponsor Respironics International, Inc (France)
  Address Immeuble Hermès
20, rue Jacques Daguerre
Rueil Malmaison
  City/town Paris
  Zip/Postcode 92565
  Country France
  Sponsor website: http://www.respironics.com
Date applied 16/04/2007
Last edited 11/12/2012
Date ISRCTN assigned 16/05/2007
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