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
Protocol serial number	N0542102350
Sponsor	Department of Health (UK)
Funder	Cambridge Consortium - Papworth Hospital NHS Trust (UK)

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

Mrs Deborah Watts
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/08/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

RSSC

Cambridge
CB3 8RE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan