Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00811668
Protocol/serial number
Wi_VentCR_12/2008
Study information
Scientific title
Comparison of treatment with continuous positive airway pressure (CPAP) and treatment with adaptive assisted ventilation (SOMNOventCR®) in patients with combined obstructive sleep apnoea and Cheyne-Stokes respiration
Acronym
Study hypothesis
The goal of the study was to compare this new therapeutic option (SOMNOvent CR®) with the established method of continuous positive airway pressure (CPAP) in patients with combination of obstructive sleep-apnoea syndrome and Cheyne-Stokes respiration with underlying heart disease.
Ethics approval
Ethics Committee of the University of Witten/Herdecke (Universität Witten/Herdecke e.V.), approved in May 2008 (ref: 13/2008)
Study design
Randomised controlled cross-over single-blind single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obstructive sleep apnoea, Cheyne-Stokes respiration
Intervention
This is a cross-over study. CPAP therapy with SOMNOsoft plus® for 4 weeks versus adaptive servo-ventilation therapy with SOMNOvent CR® for 4 weeks. There is a washout period of 1 week between the treatments.
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measures
The central AHI, assessed by polysomnography at baseline, after four weeks therapy, and (after the wash-out period) after four weeks with the other therapy (i.e. 9 weeks).
Secondary outcome measures
1. Total AHI, assessed by polysomnography at baseline, after four weeks therapy, and (after the wash-out period) after four weeks with the other therapy (i.e. 9 weeks)
2. Left ventricular ejection fraction, assessed by echocardiography at baseline, after 4 weeks therapy, and (after the wash-out period) after four weeks with the other therapy (i.e. 9 weeks)
3. Six minutes walking test at baseline, after 4 weeks therapy, and (after the wash-out period) after four weeks with the other therapy (i.e. 9 weeks)
4. Patients' questionnaire at baseline, after 4 weeks therapy, and (after the wash-out period), after four weeks with the other therapy (i.e. 9 weeks). This will include assessment of subjective satisfaction with the therapy.
5. Minimum and middle oxygen saturation, assessed by polysomnography at baseline, after four weeks therapy, and (after the wash-out period) after four weeks with the other therapy (i.e. 9 weeks)
6. Compliance, after 4 weeks therapy, and (after the wash-out period) after 4 weeks with the other therapy (i.e. 9 weeks)
Overall trial start date
13/05/2008
Overall trial end date
31/07/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men and women greater than 18 years
2. Diagnosis of arterial hypertension, coronary heart disease or dilative cardiomyopathy
3. Combined sleep apnoea syndrome with a total value of apnoea-hypopnoea index (AHI) greater than 15 per hour and a rate up to 20% of central events or periodic breathing
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Heart failure New York Heart Association (NYHA) class IV
2. Myocardial infarction, unstable angina pectoris or cardiac surgery within the last three months
3. AHI less than 15 per hour
4. Obstructive breathing disturbances up to 80%
5. Pregnancy
6. Absence of declaration of consent
7. Malign diseases
8. Serious (severe) chronic oxygen-requiring pulmonary illness
9. Aged under 18 years
Recruitment start date
13/05/2008
Recruitment end date
31/07/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Institut für Pneumologie an der Universität Witten/Herdecke
Solingen
42699
Germany
Sponsor information
Organisation
Bethanien Science Institute (Wissenschaftliches Institut Bethanien e.V.) (Germany)
Sponsor details
Aufderhöher Str. 169-175
Solingen
42699
Germany
Sponsor type
Research organisation
Website
Funders
Funder type
University/education
Funder name
University of Witten/Herdecke (Universität Witten/Herdecke) (Germany) - Institute for Pneumology (Institut für Pneumologie) (ref: Wi_VentCR_12/2008)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary