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 |
| Protocol serial number | SPGS764 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South East (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Improvements in excessive daytime sleepiness and self-reported health status |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Health Services Research Unit
Oxford
OX3 7LF
United Kingdom
OX3 7LF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
