Randomised 12 month trial of Non-Invasive Ventilation (NIV) with or without oxygen versus oxygen alone in treatment of sleep disordered breathing in Cystic Fibrosis
Phase 3
Completed
- Conditions
- Cystic FibrosisHuman Genetics and Inherited Disorders - Cystic fibrosis
- Registration Number
- ACTRN12605000420640
- Lead Sponsor
- SWSAHS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Stable CF adults with total sleep time minimum average oxygen saturation <=90%
Exclusion Criteria
Acute unstable hypercapnic respiratory failure (PaCO2>60; eligible for randomisation after acute treatment if stable off NIV for a minimum of two weeks); severe co-existing disease; persistent pneumothoraces; sputum colonised with burkolderia cepacia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method