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 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

Wissenschaftliches Institut Bethanien e.V.
Aufderhoherstrasse 169
Solingen
42699
Germany

Study information

Study designRandomised controlled double blind trial of BiPAP® autoSV™ therapy versus CPAP
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesBiPAP® 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) studiedSleep disordered breathing and cardiovascular disease.
InterventionControl:
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 typeOther
Primary outcome measureCentral AHI, measured at baseline, 3 and 12 months.
Secondary outcome measures1. 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 date01/01/2007
Completion date01/07/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants70
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2007
Date of final enrolment01/07/2008

Locations

Countries of recruitment

  • Germany

Study participating centre

Wissenschaftliches Institut Bethanien e.V.
Solingen
42699
Germany

Sponsor information

Respironics International, Inc (France)
Industry

Immeuble Hermès
20, rue Jacques Daguerre
Rueil Malmaison
Paris
92565
France

Website http://www.respironics.com
ROR logo "ROR" https://ror.org/05jz46060

Funders

Funder type

Industry

Respironics International, Inc (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2012 Yes No