Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
26/01/2010
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 Crispin Jenkinson

ORCID ID

Contact details

Health Services Research Unit
Division of Public Health and Primary Health Care
Institution of Health Sciences
Old Road
Headington
Oxford
OX3 7LF
United Kingdom
+44 (0)1865 226710
Crispin.Jenkinson@DPHPC.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SPGS764

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Respiratory tract diseases: Other respiratory tract disease

Intervention

Therapeutic NCPAP or sub-therapeutic NCPAP for 1 month

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Improvements in excessive daytime sleepiness and self-reported health status

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/1997

Overall trial end date

01/07/2000

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

101

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/03/1997

Recruitment end date

01/07/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Services Research Unit
Oxford
OX3 7LF
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 East (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

1. 2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10679542
2. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14535966

Publication citations

  1. Results

    Hack M, Davies RJ, Mullins R, Choi SJ, Ramdassingh-Dow S, Jenkinson C, Stradling JR, Randomised prospective parallel trial of therapeutic versus subtherapeutic nasal continuous positive airway pressure on simulated steering performance in patients with obstructive sleep apnoea., Thorax, 2000, 55, 3, 224-231.

  2. Results

    Meston N, Davies RJ, Mullins R, Jenkinson C, Wass JA, Stradling JR, Endocrine effects of nasal continuous positive airway pressure in male patients with obstructive sleep apnoea., J. Intern. Med., 2003, 254, 5, 447-454.

Additional files

Editorial Notes