Contact information
Type
Scientific
Primary contact
Dr Adrian Kendrick
ORCID ID
Contact details
United Bristol Health Care Trust
The Sleep Unit
Bristol General Hospital
Bristol
BS1 6SY
United Kingdom
Adrian.Kendrick@UHBristol.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R/32/01.98/Kendrick/S
Study information
Scientific title
A double-blind randomised controlled trial of nasal continuous positive airway pressure (CPAP) in patients with obstructive sleep apnoea
Acronym
Study hypothesis
Does nasal Continuous Positive Airways Pressure (CPAP) significantly reduce symptoms in patients with obstructive sleep apnoea?
Ethics approval
Not provided at time of registration
Study design
Double blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Respiratory tract diseases: Obstructive sleep apnoea
Intervention
Not provided at time of registration
Intervention type
Other
Phase
Not Specified
Drug names
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 trial start date
05/10/1998
Overall trial end date
31/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
05/10/1998
Recruitment end date
31/12/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
United Bristol Health Care Trust
Bristol
BS1 6SY
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South West (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
No publication intended as of 21/09/2011