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 |
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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
Scientific
RSSC
Papworth Hospital NHS Trust
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/12/2002 |
Completion date | 31/08/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 32 |
Key inclusion criteria | 32 patients will be recruited from new patients presenting with OSA who are to be treated with CPAP |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/12/2002 |
Date of final enrolment | 31/08/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
RSSC
Cambridge
CB3 8RE
United Kingdom
CB3 8RE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
Cambridge Consortium - Papworth Hospital NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |