Randomised controlled trial (RCT) of continuous positive airways pressure therapy (CPAP) versus placebo in the treatment of sleep apnoea
| ISRCTN | ISRCTN84891166 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84891166 |
| Secondary identifying numbers | SPGS764 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 26/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Crispin Jenkinson
Scientific
Scientific
Health Services Research Unit
Division of Public Health and Primary Health Care
Institution of Health Sciences
Old Road
Headington
Oxford
OX3 7LF
United Kingdom
| Phone | +44 (0)1865 226710 |
|---|---|
| Crispin.Jenkinson@DPHPC.ox.ac.uk |
Study information
| Study design | Randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Nasal continuous positive airway pressure NCPAP) is widely used as a treatment for obstructive sleep apnoea without previous good evidence from a randomised controlled trial of the therapy against a well matched placebo. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory tract diseases: Other respiratory tract disease |
| Intervention | Therapeutic NCPAP or sub-therapeutic NCPAP for 1 month |
| Intervention type | Other |
| Primary outcome measure | Improvements in excessive daytime sleepiness and self-reported health status |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/03/1997 |
| Completion date | 01/07/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 101 |
| Key inclusion criteria | 1. 101 men attending Osler Chest Unit, Churchill Hospital Epworth 2. Sleepiness score of >10 and 10hr of >4% Sa02 dips on overnight sleep study 3. Aged between 30-65 years |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/03/1997 |
| Date of final enrolment | 01/07/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Health Services Research Unit
Oxford
OX3 7LF
United Kingdom
OX3 7LF
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South East (UK)
No information available
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 | 01/03/2000 | Yes | No | |
| Results article | results | 01/11/2003 | Yes | No |
