A comparative study of humidification and a nasal spray for the treatment of nasal symptoms experienced by patients using continuous positive airway pressure (CPAP) via a mask

ISRCTN ISRCTN75033377
DOI https://doi.org/10.1186/ISRCTN75033377
Secondary identifying numbers N0542102350
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
16/09/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
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

Mrs Deborah Watts
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNervous System Diseases: obstructive sleep apnoea (OSA)
Intervention32 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 typeOther
Primary outcome measurePatients' 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 measuresNot provided at time of registration
Overall study start date01/12/2002
Completion date31/08/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants32
Key inclusion criteria32 patients will be recruited from new patients presenting with OSA who are to be treated with CPAP
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/12/2002
Date of final enrolment31/08/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

RSSC
Cambridge
CB3 8RE
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Cambridge Consortium - Papworth Hospital NHS Trust (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