Comparison of continuous positive airway pressure (CPAP) with SOMNOventCR® in patients with combined obstructive sleep apnoea and Cheyne-Stokes respiration
| ISRCTN | ISRCTN94330341 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94330341 |
| ClinicalTrials.gov number | NCT00811668 |
| Secondary identifying numbers | Wi_VentCR_12/2008 |
- Submission date
- 08/01/2009
- Registration date
- 05/02/2009
- Last edited
- 18/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Wolfgang Galetke
Scientific
Scientific
Institut für Pneumologie an der Universität Witten/Herdecke
Aufderhöher Str. 169-175
Solingen
42699
Germany
Study information
| Study design | Randomised controlled cross-over single-blind single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Ethics Committee of the University of Witten/Herdecke (Universität Witten/Herdecke e.V.), approved in May 2008 (ref: 13/2008) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 13/05/2008 |
| Completion date | 31/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/05/2008 |
| Date of final enrolment | 31/07/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Institut für Pneumologie an der Universität Witten/Herdecke
Solingen
42699
Germany
42699
Germany
Sponsor information
Bethanien Science Institute (Wissenschaftliches Institut Bethanien e.V.) (Germany)
Research organisation
Research organisation
Aufderhöher Str. 169-175
Solingen
42699
Germany
| Website | http://www.klinik-bethanien.de/cms.cgi |
|---|---|
"ROR" |
https://ror.org/03ndabk35 |
Funders
Funder type
University/education
University of Witten/Herdecke (Universität Witten/Herdecke) (Germany) - Institute for Pneumology (Institut für Pneumologie) (ref: Wi_VentCR_12/2008)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2014 | 18/02/2019 | Yes | No |
Editorial Notes
18/02/2019: Publication reference added.
14/02/2019: No publications found. Verifying results with principal investigator.
