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

Oxidative stress and obstructive sleep apnoea; effect of withdrawing continuous positive airway pressure therapy: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN73047833

Enrollment

Registered

2012-08-01

Start date

2012-09-03

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep apnoea Nervous System Diseases Sleep apnoea

Interventions

Current interventions as of 07/05/2013: Sham/placebo CPAP at subtherapeutic levels: subtherapeutic CPAP (<1cm H2O) nightly during sleep time for 2 weeks. Using a ResMed Autoset, the su

Eligibility

Sex/Gender

All

Inclusion 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 (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

Exclusion criteria: 1. Previous ventilatory failure (awake resting arterial oxygen saturation 6kPa) or severe respiratory disorders other than OSA 2. Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (>180/110mmHg), severe arterial hypotension (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)

Design outcomes

Primary

Measure	Time frame
Change in plasma malondialdehyde over the two weeks trial period, CPAP withdrawal (sham CPAP) versus control (continuing CPAP) E55	—

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026