Condition category
Nervous System Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/09/2014
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

Mrs Deborah Watts

ORCID ID

Contact details

RSSC
Papworth Hospital NHS Trust
Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0542102350

Study information

Scientific title

Acronym

Study hypothesis

The research will compare outcomes for patients treated with syntaris nasal spray and heated humidification with regard to:
1. Incidence and severity of self-assessed nasal dryness, runny nose, blocked nose
2. Compliance with CPAP therapy
3. Annualised cost of treatment

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Nervous System Diseases: obstructive sleep apnoea (OSA)

Intervention

32 patients will be recruited from new patients presenting with OSA who are to be treated with CPAP.

The study arms are:
1. Nasal spray
2. Headed humidification

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patients' nasal symptoms will be assessed using a self-scored scale. This will determine baseline symptoms, the effects of CPAP and of nasal sprays/humidification

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2002

Overall trial end date

31/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

32 patients will be recruited from new patients presenting with OSA who are to be treated with CPAP

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

32

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/2002

Recruitment end date

31/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

RSSC
Cambridge
CB3 8RE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Cambridge Consortium - Papworth Hospital NHS Trust (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

Publication citations

Additional files

Editorial Notes