Comparison of continuous positive airway pressure (CPAP) with SOMNOventCR® in patients with combined obstructive sleep apnoea and Cheyne-Stokes respiratio

Phase 4

Completed

• Conditions: Nervous System Diseases; Sleep disorders; Obstructive sleep apnoea, Cheyne-Stokes respiration

• Registration Number: ISRCTN94330341
• Lead Sponsor: Bethanien Science Institute (Wissenschaftliches Institut Bethanien e.V.) (Germany)

Brief Summary

2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24841107 [added 18/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-05
• Study Completion: 2009-07-31
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).