ISRCTN93153804
Completed
N/A
Continuous positive airway pressure therapy withdrawal - a model to evaluate treatment modalities for sleep apnoea: a randomised controlled trial
niversity Hospital of Zurich (Switzerland)0 sites40 target enrollmentJuly 14, 2009
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obstructive sleep apnoea
- Sponsor
- niversity Hospital of Zurich (Switzerland)
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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