Contact information
Type
Scientific
Primary contact
Dr Malcolm Kohler
ORCID ID
Contact details
Sleep Disorders Centre and Pulmonary Division
University Hospital of Zurich
Raemistrasse 100
Zurich
8091
Switzerland
+41 (0)44 255 97 51
Malcolm.K@bluewin.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
V1.1
Study information
Scientific title
Continuous positive airway pressure therapy withdrawal - a model to evaluate treatment modalities for sleep apnoea: a randomised controlled trial
Acronym
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
Severity and symptoms of OSA, measured at least at baseline, after 1 week and after 2 weeks.
Secondary outcome measures
1. Blood pressure
2. Endothelial function
3. Systemic inflammation
Measured at least at baseline, after 1 week and after 2 weeks.
Overall trial start date
01/07/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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)
Recruitment start date
01/07/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Switzerland
Trial participating centre
Sleep Disorders Centre and Pulmonary Division
Zurich
8091
Switzerland
Sponsor information
Organisation
University Hospital of Zurich (Switzerland)
Sponsor details
c/o Dr Malcolm Kohler
Sleep Disorders Centre and Pulmonary Division
Raemistrasse 100
Zurich
8091
Switzerland
Malcolm.K@bluewin.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Swiss National Science Foundation (Switzerland) (ref: 32003B_124915/1)
Alternative name(s)
Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNSF, FNS, SNF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21836134
Publication citations
-
Results
Kohler M, Stoewhas AC, Ayers L, Senn O, Bloch KE, Russi EW, Stradling JR, Effects of continuous positive airway pressure therapy withdrawal in patients with obstructive sleep apnea: a randomized controlled trial., Am. J. Respir. Crit. Care Med., 2011, 184, 10, 1192-1199, doi: 10.1164/rccm.201106-0964OC.