ISRCTN17987510
Completed
未知
The effects of supplemental oxygen on obstructive sleep apnoea (OSA) and its vascular consequences during continuous positive airway pressure therapy withdrawal
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Topic: Respiratory disorders
- Sponsor
- niversity of Oxford
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30025470 2021 results in https://pubmed.ncbi.nlm.nih.gov/33991325/ (added 17/05/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Objectively confirmed obstructive sleep apnoea (at the time of original diagnosis) with an oxygen desaturation index (ODI, \=4% dips) of \>20/h or/and an apnoea/ hypopnoea index of \>20/h (this threshold will exclude subjects with borderline OSA, in whom there may be little treatment effect).
- •2\. Currently \>20/h oxygen desaturations (\=4% dips) returning on any night during an ambulatory nocturnal pulse oximetry performed during a 4\-night period without CPAP.
- •3\. Treated with CPAP for more than 12 months, minimum compliance 4h per night, AHI \<10 with treatment (according to machine download data) and ODI\<10 confirmed on CPAP during screening oximetry.
- •4\. Written informed consent
- •5\. Upper Age Limit 75 years, lower Age Limit 20 years
Exclusion Criteria
- •1\. Previous ventilatory failure (awake resting arterial oxygen saturation \<93% or arterial PCO2 \> 6kPa) or severe respiratory disorders other than OSA
- •2\. Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (\>180/110mmHg), severe arterial hypotension (\<90/60mmHg).
- •3\. Previously diagnosed with CheyneStokes breathing.
- •4\. Current professional driver.
- •5\. Any sleep related accident.
- •6\. Age \<20 or \>75 years at trial entry.
- •7\. Severe nasal congestion.
- •8\. Mental or physical disability precluding informed consent or compliance with the protocol
- •9\. Nonfeasible trial followup (for example, distance from follow\-up centre, physical inability).
- •10\. Current smoker
Outcomes
Primary Outcomes
Not specified
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