Multi-centre randomised controlled trial to investigate the efficacy of nasal continuous positive airway pressure treatment to reduce cardiovascular risk and symptoms in mild to moderate sleep apnoea
- Conditions
- Sleep apnoeaNervous System Diseases
- Registration Number
- ISRCTN34164388
- Lead Sponsor
- Oxford Radcliffe Hospitals NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 400
1. Objectively confirmed obstructive sleep apnoea on respiratory polysomnography, with a >4% arterial oxygen desaturation index of >7.5/hour
2. Written informed consent
1. Sleep apnoea symptoms of sufficient severity that CPAP is mandated by current trial evidence, such that randomisation to a control would be unethical (this decision is in the hands of the randomising physician as the equipoise point varies between units, but guidance on this is presented later)
2. Ventilatory failure (awake resting arterial oxygen saturation <93% or arterial pCO2 >6kPa)
3. Clinic BP more than 180/110
4. Cheyne-Stokes breathing on respiratory polysomnography
5. Current Heavy Goods Vehicle or Public Service Vehicle driving licence holder
6. Any sleep related accident
7. Age <45 or >75 years at trial entry (age range selected as it is typical for patients with OSA and will have a significant cardiovascular event rate)
8. Previous exposure to CPAP or non-invasive ventilation
9. Mental or physical disability precluding informed consent or compliance with the protocol for the duration of the study
10. Non-feasible trial follow-up (for example, distance from follow-up centre, physical inability)
11. Any co-incidental illness making survival for two years unlikely
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Reduction in the cardiovascular risk using the Framingham score<br>2. Reduction in Epworth Sleepiness Score
- Secondary Outcome Measures
Name Time Method 1. Fall in insulin resistance<br>2. Fall in HbA1c<br>3. Platelet activation<br>4. BP variability<br>5. Fasting triglycerides<br>6. Obesity and its distribution<br>7. Carotid wall volume<br>8. Brain magnetic resonance imaging (MRI) indices of hypertensive damage<br>9. Diastolic function<br>10. Pulse wave analysis<br>11. Reduction in adverse cardiovascular events<br>12. Improvement in self assessed health status and ability to resist sleep<br>13. Reduction health services utilisation