Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000208505
Ethics application status
Not yet submitted
Date submitted
19/05/2006
Date registered
30/05/2006
Date last updated
30/05/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Nasal hyper reactivity in CPAP patients
Scientific title
Assessment of nasal hyper reactivity with light absorption technique “Rhinolux” in patients with obstructive sleep apnoea syndrome and controls before and after Continuous Positive Airway Pressure (CPAP) intervention
Secondary ID [1] 263 0
A CTN application has been submitted
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasal hyper reactivity in obstructive sleep apnoea syndrome 1186 0
Condition category
Condition code
Respiratory 1269 1269 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After an initial measurement with acoustic rhinometry, rhinomanometry and Rhinolux the subjects are treated with CPAP while lying down. First they will have the nasal prongs of the CPAP fitted with no air pressure for 10 minutes, and then a CPAP pressure of 8 cm H2O will be applied for 20 minutes. The Rhinolux will be fitted during the CPAP provocation to assess changes in nasal mucosal blood flow. Finally, acoustic rhinometry, rhinomanometry and Rhinolux are repeated in sitting and reclining position. Subjective symptoms of nasal congestion will be registered by the subjects on a visual analogue scale sitting and lying down, before and after the CPAP intervention (4 times).
Intervention code [1] 1050 0
Early detection / Screening
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1715 0
Increased nasal mucosal thickening/bloodflow compared to baseline
Timepoint [1] 1715 0
After 20 minutes of CPAP 8 cm H20 with nasal prongs
Secondary outcome [1] 3064 0
Percieved nasal congestion on visual analogue scale after 20 minutes of CPAP 8 cm H2O with nasal prongs compared to baseline.
Timepoint [1] 3064 0

Eligibility
Key inclusion criteria
Obstructive sleep apnoea syndrome (OSAS) who attend the sleep investigation unit for CPAP titration and who have not been treated with CPAP during the last year.Non-smoking healthy control subjects without any history of nasal disease, previous nasal surgery or current medication. Negative skin prick test.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current treatment with nasal steroids or decongestantsNasal polyposisPrevious nasal surgery (septoplasty, turbinectomy, endoscopic sinus surgey)Previous nasal trauma (nasal bone fracture )Previous nasal CPAP treatment less than 1 year ago.Positive skin prick test in controls.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Validation of the Rhinolux
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1390 0
Other
Name [1] 1390 0
The Woolcock Institute of Medical Research
Country [1] 1390 0
Australia
Primary sponsor type
Other
Name
The Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 1223 0
University
Name [1] 1223 0
The Department of Occupational and Environmental Medicine, Sahlgrenska Academy, Gothenburgh, Sweden
Address [1] 1223 0
Country [1] 1223 0
Sweden

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2743 0
Ethics Review Committee, RPAH Zone
Ethics committee address [1] 2743 0
Research Development Office, Level 8, Building 14, Royal Prince Alfred Hospital, Camperdown NSW 2050
Ethics committee country [1] 2743 0
Australia
Date submitted for ethics approval [1] 2743 0
Approval date [1] 2743 0
Ethics approval number [1] 2743 0
X06-0075

Summary
Brief summary
Nasal hyper reactivity is characterised by a reflex mediated increased sensitivity to inhaled unspecific irritants such as cold air, perfumes and smoke. Patients with obstructive sleep apnoea syndrome (OSAS) are treated with a “continuous positive air way pressure” (CPAP) device that relies upon a good nasal patency during sleep. The present study aims at evaluating a new non-invasive device, the Rhinolux, to identify patients with an increased risk of having nasal hyper reactivity during CPAP treatment. The Rhinolux is an oximetry device that measures changes in nasal blood flow by light absorption in haemoglobin.
The majority of the patients in this study will not have tested CPAP before eventhough they have been given a description of the treatment procedure. To control for the bias that having prongs in the nose could effect the nasal blood flow, all subjects will initially wear the prongs for 10 minutes before the CPAP pressure is applied. In this sence the study could be considered to be single blind because only the examiner will be fully aware at what time the CPAP pressure is turned on.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36276 0
Address 36276 0
Country 36276 0
Phone 36276 0
Fax 36276 0
Email 36276 0
Contact person for public queries
Name 10239 0
Dr Brendon Yee
Address 10239 0
Staff Physician
Department of Respiratory and Sleep Medicine
Research Fellow
Sleep Investigation Unit
Royal Prince Alfred Hospital
E11
Missenenden Road
Camperdown NSW 2006
Country 10239 0
Australia
Phone 10239 0
+61 2 95158190
Fax 10239 0
+61 2 95157196
Email 10239 0
brendony@med.usyd.edu.au
Contact person for scientific queries
Name 1167 0
Dr Johan Hellgren
Address 1167 0
Visiting Research Fellow
The Woolcock Institute of Medical Research
Royal Prince Alfred Hospital
The Page Chest Pavilion
Level 7
Missenden Road
Camperdown NSW 2006
Country 1167 0
Australia
Phone 1167 0
+61 2 93514145
Fax 1167 0
+61 2 95157196
Email 1167 0
johanh@med.usyd.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.