Evaluate the effectiveness of servo-ventilation therapy in patients with co-existing sleep related breathing disorders and heart failure [Evaluation de la BiPAP autoSV Advanced dans le traitement du syndrome dapnées mixtes du sommeil chez les patients ayant une insuffisance cardiaque congestive]

ISRCTN	ISRCTN26654460
DOI	https://doi.org/10.1186/ISRCTN26654460
Protocol serial number	EAME09ASV01
Sponsor	Phillips Respironics International Inc. (France)
Funder	Phillips Respironics International Inc. (France)

Submission date: 08/04/2010
Registration date: 22/04/2010
Last edited: 01/03/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jean-Louis Pepin
Scientific

Pôle de Rééducation et Physiologie
Laboratoire dExploration Fonctionnelles Cardio-Respiratoires et Laboratoire du Sommeil
CHU de Grenoble
BP 217
Grenoble
38043
France

Study information

Primary study design	Observational
Study design	Observational longitudinal case-control multicentre study
Secondary study design	Case-control study
Study type	Participant information sheet
Scientific title	Evaluate the effectiveness of servo-ventilation therapy in patients with co-existing sleep related breathing disorders and heart failure: a 6-month longitudinal case-control observational study
Study objectives	Servo-ventilation therapy may improve the quality of life and prognosis in patients with co-existing sleep disordered breathing and heart failure. This is an observational trial where we would like to follow up a group of such patients and to evaluate the outcomes.
Ethics approval(s)	Comité de Protection des Personnes Sud Est V approved on the 13th May 2009 (ref: CPP 09-RESP-1)
Health condition(s) or problem(s) studied	Sleep related breathing disorders/heart failure
Intervention	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. Clinical evaluation 1.3. Arterial and blood review 1.4. Cardiac evaluation 1.5. PSG control night 2. Second Visit at 10 days (V1): 2.1. Clinical evaluation 2.2. Blood pressure measurement 2.3. Questionnaires 2.4. Device compliance download 2.5. Polygraphy ambulatory recording 3. Third Visit at 1 month (V2): 3.1. Clinical evaluation 3.2. Blood pressure measurement 3.3. Questionnaires 3.4. Device compliance download 4. Fourth Visit at 3 months (V3): 4.1. Clinical evaluation 4.2. Blood pressure measurement 4.3. Questionnaires 4.4. Device compliance download 4.5. Effort test 4.6. Walking test 4.7. Blood gases/NTProBNP 5. Fifth Visit at 6 months (V4): 5.1. Clinical evaluation 5.2. Blood pressure measurement 5.3. Questionnaires 5.4. Device compliance download 5.5. Scan or isotope imaging 5.6. Effort test 5.7. Measuring the ventilatory response to CO2 5.8. Walking test 5.9. Blood gases/determination of NT-proBNP 5.10. PSG control night
Intervention type	Other
Primary outcome measure(s)	Assess the correction of the apnoea/hypopnoea index (AHI); the method to evaluate this outcome will be the PSG recording.
Key secondary outcome measure(s)	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
Completion date	10/04/2011
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	40
Key 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
Key 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
Date of first enrolment	10/04/2010
Date of final enrolment	10/04/2011

Locations

Countries of recruitment

France

Study participating centre

Pôle de Rééducation et Physiologie

Grenoble
38043
France

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Evaluate the effectiveness of servo-ventilation therapy in patients with co-existing sleep related breathing disorders and heart failure [Evaluation de la BiPAP autoSV Advanced dans le traitement du syndrome dapnées mixtes du sommeil chez les patients ayant une insuffisance cardiaque congestive]