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
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