Oxidative stress and obstructive sleep apnoea; effect of withdrawing continuous positive airway pressure therapy

Completed

• Conditions: Sleep apnoea; Nervous System Diseases

• Registration Number: ISRCTN73047833
• Lead Sponsor: Oxford University Hospitals NHS Trust (UK)

Brief Summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22453648 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26022961 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28153870

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-01
• Study Completion: 2013-08-30
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Objectively confirmed obstructive sleep apnoea (at the time of original diagnosis) with an oxygen desaturation index (ODI, =4% dips) of >20 (this threshold will exclude subjects with borderline OSA, in whom there may be little experimental effect)
2. Currently >20/h oxygen desaturations (=4% dips) returning during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP, prior to entry into the study
3. Treated with CPAP for more than 12 months, minimum compliance 4h per night, AHI <10 with treatment (derived from CPAP download data)
4. Written informed consent

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 Cheyne-Stokes breathing
4. Current professional driver
5. History of any sleep-related driving or other accident
6. Age <20 or >75 years at trial entry
7. Acute upper respiratory infection
8. Mental or physical disability precluding informed consent or compliance with the protocol
9. 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
Change in plasma malondialdehyde over the two weeks trial period, CPAP withdrawal (sham CPAP) versus control (continuing CPAP) E55

Secondary Outcome Measures

Name	Time	Method
<br> 1. Other measures of oxidative stress<br> 2. Blood pressure and heart rate<br> 3. Overnight catecholamine secretion<br> 4. Subjective sleepiness<br> 5. OSA severity assessed by nocturnal respiratory disturbances (ODI/AHI from polygraphic sleep studies, and ODI/AHI from nightly monitoring)<br>