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]

ISRCTN ISRCTN26654460
DOI https://doi.org/10.1186/ISRCTN26654460
Secondary identifying numbers EAME09ASV01
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 d’Exploration Fonctionnelles Cardio-Respiratoires et Laboratoire du Sommeil
CHU de Grenoble
BP 217
Grenoble
38043
France

Study information

Study designObservational longitudinal case-control multicentre study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluate 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 objectivesServo-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) studiedSleep related breathing disorders/heart failure
InterventionAfter 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 typeOther
Primary outcome measureAssess the correction of the apnoea/hypopnoea index (AHI); the method to evaluate this outcome will be the PSG recording.
Secondary outcome measures1. 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
Overall study start date10/04/2010
Completion date10/04/2011
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants40
Key inclusion criteria1. 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 criteria1. 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 enrolment10/04/2010
Date of final enrolment10/04/2011

Locations

Countries of recruitment

  • France

Study participating centre

Pôle de Rééducation et Physiologie
Grenoble
38043
France

Sponsor information

Phillips Respironics International Inc. (France)
Industry

2 rue du château de Bel Air
Carquefou
44470
France

Website http://www.medical.philips.com/main/homehealth/index.wpd
ROR logo "ROR" https://ror.org/05jz46060

Funders

Funder type

Industry

Phillips 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