Continuous positive airway pressure therapy withdrawal - a model to evaluate treatment modalities for sleep apnoea
- Conditions
- Obstructive sleep apnoeaNervous System DiseasesSleep disorders
- Registration Number
- ISRCTN93153804
- Lead Sponsor
- niversity Hospital of Zurich (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. Objectively confirmed obstructive sleep apnoea with an original oxygen desaturation index (ODI) (greater than or equal to 4% dips) of between 10 and 50/h
2. Currently greater than 10 oxygen desaturations (greater than or equal to 4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP
3. Treated with CPAP for more than 12 months, minimal compliance 4 hours per night
4. Written informed consent
5. Aged 20 - 75 years (inclusive), either sex
1. Previous ventilatory failure (awake resting arterial oxygen saturation less than 93% or arterial partial pressure of carbon dioxide [PCO2] greater than 6 kPa)
2. Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (greater than 180/110 mmHg)
3. Previously diagnosed with Cheyne-Stokes breathing
4. Current professional driver
5. Any sleep related accident
6. Aged less than 20 or greater than 75 years at trial entry
7. Mental or physical disability precluding informed consent or compliance with the protocol
8. Non-feasible trial follow-up (for example, distance from follow-up centre, physical inability)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity and symptoms of OSA, measured at least at baseline, after 1 week and after 2 weeks.
- Secondary Outcome Measures
Name Time Method 1. Blood pressure<br>2. Endothelial function <br>3. Systemic inflammation<br><br>Measured at least at baseline, after 1 week and after 2 weeks.