Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

No publication intended as of 21/09/2011

Publication citations

Additional files

Editorial Notes