Continuous positive airway pressure therapy withdrawal - a model to evaluate treatment modalities for sleep apnoea

ISRCTN	ISRCTN93153804
DOI	https://doi.org/10.1186/ISRCTN93153804
Protocol serial number	V1.1
Sponsor	University Hospital of Zurich (Switzerland)
Funder	Swiss National Science Foundation (Switzerland) (ref: 32003B_124915/1)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Malcolm Kohler
Scientific

Sleep Disorders Centre and Pulmonary Division
University Hospital of Zurich
Raemistrasse 100
Zurich
8091
Switzerland

Phone	+41 (0)44 255 97 51
Email	Malcolm.K@bluewin.ch

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Continuous positive airway pressure therapy withdrawal - a model to evaluate treatment modalities for sleep apnoea: a randomised controlled trial
Study objectives	Continuous positive airway pressure (CPAP) therapy withdrawal will result in gradual deterioration in daytime symptoms of obstructive sleep apnoea (OSA), sleep study parameters of OSA severity and an increase of blood pressure, endothelial dysfunction and systemic inflammation.
Ethics approval(s)	Local ethics committee of the University Hospital of Zurich approved on the 13th January 2009 (ref: EK-1600)
Health condition(s) or problem(s) studied	Obstructive sleep apnoea
Intervention	Obstructive sleep apnoea patients under treatment with continuous positive airway pressure (CPAP) will be randomised to either continue with CPAP or to sham CPAP for 2 weeks. Total time of follow-up is 2 weeks.
Intervention type	Other
Primary outcome measure(s)	Severity and symptoms of OSA, measured at least at baseline, after 1 week and after 2 weeks.
Key secondary outcome measure(s)	1. Blood pressure 2. Endothelial function 3. Systemic inflammation Measured at least at baseline, after 1 week and after 2 weeks.
Completion date	31/12/2010

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key 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
Key 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)
Date of first enrolment	01/07/2009
Date of final enrolment	31/12/2010

Sleep Disorders Centre and Pulmonary Division

Zurich
8091
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/11/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes