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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN70594408

Enrollment

Registered

2007-05-16

Start date

2007-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep disordered breathing and cardiovascular disease. Circulatory System Cardiovascular disease

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Central AHI, measured at baseline, 3 and 12 months.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026