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Clinical Trials/ISRCTN17987510
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

niversity of Oxford0 sites25 target enrollmentFebruary 19, 2015

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

Registry
who.int
Start Date
February 19, 2015
End Date
December 31, 2016
Last Updated
4 years ago
Study Type
Interventional
Sex
All

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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