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

ISRCTN ISRCTN93153804
DOI https://doi.org/10.1186/ISRCTN93153804
Secondary identifying numbers V1.1
Submission date
13/05/2009
Registration date
14/07/2009
Last edited
15/08/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleContinuous positive airway pressure therapy withdrawal - a model to evaluate treatment modalities for sleep apnoea: a randomised controlled trial
Study objectivesContinuous 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) studiedObstructive sleep apnoea
InterventionObstructive 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 typeOther
Primary outcome measureSeverity and symptoms of OSA, measured at least at baseline, after 1 week and after 2 weeks.
Secondary outcome measures1. Blood pressure
2. Endothelial function
3. Systemic inflammation

Measured at least at baseline, after 1 week and after 2 weeks.
Overall study start date01/07/2009
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2009
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Sleep Disorders Centre and Pulmonary Division
Zurich
8091
Switzerland

Sponsor information

University Hospital of Zurich (Switzerland)
Hospital/treatment centre

c/o Dr Malcolm Kohler
Sleep Disorders Centre and Pulmonary Division
Raemistrasse 100
Zurich
8091
Switzerland

Email Malcolm.K@bluewin.ch
Website http://www.unizh.ch/
ROR logo "ROR" https://ror.org/01462r250

Funders

Funder type

Research organisation

Swiss National Science Foundation (Switzerland) (ref: 32003B_124915/1)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
Location
Switzerland

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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