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
Scientific
Sleep Disorders Centre and Pulmonary Division
University Hospital of Zurich
Raemistrasse 100
Zurich
8091
Switzerland
| Phone | +41 (0)44 255 97 51 |
|---|---|
| Malcolm.K@bluewin.ch |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/07/2009 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Sleep Disorders Centre and Pulmonary Division
Zurich
8091
Switzerland
8091
Switzerland
Sponsor information
University Hospital of Zurich (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Malcolm Kohler
Sleep Disorders Centre and Pulmonary Division
Raemistrasse 100
Zurich
8091
Switzerland
| Malcolm.K@bluewin.ch | |
| Website | http://www.unizh.ch/ |
"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)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
