Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Rand001
Study information
Scientific title
Acronym
Study hypothesis
BiPAP® autoSV™ is superior to Continuous Positive Airway Pressure (CPAP) in reducing breathing disturbances during sleep and improving cardiac function.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/01/2007
Overall trial end date
01/07/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Participant 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
Recruitment start date
01/01/2007
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Wissenschaftliches Institut Bethanien e.V.
Solingen
42699
Germany
Sponsor information
Organisation
Respironics International, Inc (France)
Sponsor details
Immeuble Hermès
20
rue Jacques Daguerre
Rueil Malmaison
Paris
92565
France
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Respironics International, Inc (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22281801
Publication citations
-
Results
Randerath WJ, Nothofer G, Priegnitz C, Anduleit N, Treml M, Kehl V, Galetke W, Long-term auto-servoventilation or constant positive pressure in heart failure and coexisting central with obstructive sleep apnea., Chest, 2012, 142, 2, 440-447, doi: 10.1378/chest.11-2089.