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

United Bristol Health Care Trust
The Sleep Unit
Bristol General Hospital
Bristol
BS1 6SY
United Kingdom

Email Adrian.Kendrick@UHBristol.nhs.uk

Study information

Study designDouble blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA double-blind randomised controlled trial of nasal continuous positive airway pressure (CPAP) in patients with obstructive sleep apnoea
Study objectivesDoes 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) studiedRespiratory tract diseases: Obstructive sleep apnoea
InterventionNot provided at time of registration
Intervention typeOther
Primary outcome measure1. Number of hours of CPAP used per night
2. The mean number of hours usage per week
3. Epworth Score
Secondary outcome measures1. SF-36
2. Steer Clear driving simulation test
3. Sleep-wake diary data
Overall study start date05/10/1998
Completion date31/12/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment05/10/1998
Date of final enrolment31/12/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

United Bristol Health Care Trust
Bristol
BS1 6SY
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan