Sleep related breathing disorders/heart failure Nervous System Diseases Sleep disorders
Conditions
Interventions
After checking inclusion/exclusion criterias and having the patient consent signed, the following steps will be as follows:
1. First Visit (V0):
1.1. Polysomnography (PSG) diagnostic night
1.2. Clini
Sponsors
Phillips Respironics International Inc. (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with heart failure and obstructive/central sleep apnoea (no specific age range or sex) 2. Naive patients to positive airway pressure therapy 3. Apnoea/Hypopnoea Index greater than 30/h with at least 30% of central events 4. Left ventricular ejection fraction less than 45% 5. Patients with a New York Heart Association (NYHA) class between II and IV 6. Stable and optimised medical cardiac therapy since one month at least 7. Informed consent signed
Exclusion criteria
Exclusion criteria: 1. Patients with associated chronic obstructive pulmonary disease 2. Patients with unstable heart failure or stable since less than one month 3. Patients with unstable angina pectoris or stable since less than one month 4. Patients with stroke 5. Patients with ischaemic cardiomyopathy or cardiogenic oedema 6. Patients with a cardiac resynchronisation scheduled within the next 6 months 7. Patients with a valvular surgery scheduled within the next 6 months 8. Patients participating to another clinical trial or not affiliated to the social security system 9. Patients in jail or hospitalised without consent 10. Majors protected by the law or detainees 11. Minors 12. Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the correction of the apnoea/hypopnoea index (AHI); the method to evaluate this outcome will be the PSG recording. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cardiovascular function: assessing long-term changes in left ventricular ejection fraction (LVEF) when using the in BiPAP autoSV Advanced: 1.1. LVEF: assessed by measuring Scan or Isotope imaging 1.2. Left Ventricular Diastolic Function (FDVG) 1.3. Determination of NT-proBNP 2. Improvement of cardiorespiratory function in BiPAP autoSV Advanced: 2.1. Effort Test: measurement of oxygen consumption (VO2max), ventilatory threshold value, ventilatory response to CO2 (VE/VCO2) 2.2. Six-minute walk Test: to assess the distance in meters, heart rate and SaO2 at the end of trial 2.3. PSG: blood average oxygen Saturation (SaO2) and oxygen desaturation index per hour of sleep. The desaturation threshold is set at 3%. In addition, we calculate the time spent with SaO2 <90% 3. Quality of sleep: 3.1. Total time of sleep (in minutes) 3.2. Percentage of REM sleep, slow wave sleep light (I and II), and slow deep (III and IV) 3.3. Index of arousal associated with respiratory events per hour 4. Effectiveness of sleep: ratio of total sleep time and time spent in bed 5. Questionnaires: 5.1. Daytime sleepiness: Epworth Sleepiness Questionnaire (QSE) 5.2. Quality of life Questionnaire Minnesota 6. Acceptance rate expressed by: 6.1. Compliance of more than 4 hours 6.2. Percentage of patients continuing their treatment at 6 months | — |
Countries
France
Outcome results
None listed