Variable-pressure versus fixed-pressure continuous positive airway pressure (CPAP) treatment for patients with obstructive sleep apnoea/hypopnoea syndrome (OSAHS)
- Conditions
- Obstructive sleep apnoea/hypopnoea syndrome (OSAHS)Nervous System DiseasesSleep disorders
- Registration Number
- ISRCTN43085025
- Lead Sponsor
- othian NHS Board (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
1. Both males and females, between 18 and 70 years of age
2. CPAP naïve patients
3. Epworth Sleepiness Scale (ESS) >10 OR history of troublesome sleepiness when driving
4. AHI >15 on polysomnography or AHI/respiratory disturbance index (RDI) >25 on limited sleep study
1. Severe neurological deficit sufficient to compromise CPAP usability or understanding
2. Significant co-morbidity (severe or unstable respiratory, neurological, metabolic or cardiac disease)
3. Co-existing sleep disorder such as narcolepsy, periodic limb movement syndrome
4. Contra-indications to CPAP use including recent pneumothorax
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient preference, recorded once at trial end and assessed using a chi-square test.
- Secondary Outcome Measures
Name Time Method 1. Patient-orientated effectiveness of treatment (sleepiness, symptoms, side-effects)<br>2. Physiologically-orientated effectiveness of CPAP (AHI, CPAP pressure, CPAP use)