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 (NCT)	NCT00811668
Protocol serial number	Wi_VentCR_12/2008
Sponsor	Bethanien Science Institute (Wissenschaftliches Institut Bethanien e.V.) (Germany)
Funder	University of Witten/Herdecke (Universität Witten/Herdecke) (Germany) - Institute for Pneumology (Institut für Pneumologie) (ref: 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

Institut für Pneumologie an der Universität Witten/Herdecke
Aufderhöher Str. 169-175
Solingen
42699
Germany

Study information

Primary study design	Interventional
Study design	Randomised controlled cross-over single-blind single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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).
Key secondary outcome measure(s)	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)
Completion date	31/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

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?
Results article	results	01/08/2014	18/02/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/02/2019: Publication reference added.
14/02/2019: No publications found. Verifying results with principal investigator.