Condition category
Nervous System Diseases
Date applied
08/01/2009
Date assigned
05/02/2009
Last edited
06/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wolfgang Galetke

ORCID ID

Contact details

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

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

http://www.klinik-bethanien.de/cms.cgi

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

Publication citations

Additional files

Editorial Notes