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Continuous positive airway pressure therapy withdrawal - a model to evaluate treatment modalities for sleep apnoea
ISRCTN ISRCTN93153804
DOI 10.1186/ISRCTN93153804
ClinicalTrials.gov identifier
EudraCT number
Public title Continuous positive airway pressure therapy withdrawal - a model to evaluate treatment modalities for sleep apnoea
Scientific title Continuous positive airway pressure therapy withdrawal - a model to evaluate treatment modalities for sleep apnoea: a randomised controlled trial
Acronym N/A
Serial number at source V1.1
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Local ethics committee of the University Hospital of Zurich approved on the 13th January 2009 (ref: EK-1600)
Study design Randomised controlled trial
Countries of recruitment Switzerland
Disease/condition/study domain Obstructive sleep apnoea
Participants - 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
Participants - 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)
Anticipated start date 01/07/2009
Anticipated end date 31/12/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 40
Interventions 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.
Primary outcome measure(s) Severity and symptoms of OSA, measured at least at baseline, after 1 week and after 2 weeks.
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.
Sources of funding Swiss National Science Foundation (Switzerland) (ref: 32003B_124915/1)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21836134
Contact name Dr  Malcolm  Kohler
  Address Sleep Disorders Centre and Pulmonary Division
University Hospital of Zurich
Raemistrasse 100
  City/town Zurich
  Zip/Postcode 8091
  Country Switzerland
  Tel +41 (0)44 255 97 51
  Fax +41 (0)44 255 44 51
  Email Malcolm.K@bluewin.ch
Sponsor University Hospital of Zurich (Switzerland)
  Address c/o Dr Malcolm Kohler
Sleep Disorders Centre and Pulmonary Division
Raemistrasse 100
  City/town Zurich
  Zip/Postcode 8091
  Country Switzerland
  Email Malcolm.K@bluewin.ch
  Sponsor website: http://www.unizh.ch/
Date applied 13/05/2009
Last edited 15/08/2011
Date ISRCTN assigned 14/07/2009
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