A double-blind randomised controlled trial of nasal continuous positive airway pressure (CPAP) in patients with obstructive sleep apnoea
| ISRCTN | ISRCTN15092365 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15092365 |
| Secondary identifying numbers | R/32/01.98/Kendrick/S |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 21/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Adrian Kendrick
Scientific
Scientific
United Bristol Health Care Trust
The Sleep Unit
Bristol General Hospital
Bristol
BS1 6SY
United Kingdom
| Adrian.Kendrick@UHBristol.nhs.uk |
Study information
| Study design | Double blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A double-blind randomised controlled trial of nasal continuous positive airway pressure (CPAP) in patients with obstructive sleep apnoea |
| Study objectives | Does nasal Continuous Positive Airways Pressure (CPAP) significantly reduce symptoms in patients with obstructive sleep apnoea? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory tract diseases: Obstructive sleep apnoea |
| Intervention | Not provided at time of registration |
| Intervention type | Other |
| Primary outcome measure | 1. Number of hours of CPAP used per night 2. The mean number of hours usage per week 3. Epworth Score |
| Secondary outcome measures | 1. SF-36 2. Steer Clear driving simulation test 3. Sleep-wake diary data |
| Overall study start date | 05/10/1998 |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 05/10/1998 |
| Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
United Bristol Health Care Trust
Bristol
BS1 6SY
United Kingdom
BS1 6SY
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 West (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 |
