Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000630415
Ethics application status
Approved
Date submitted
27/11/2007
Date registered
12/12/2007
Date last updated
12/12/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of a Novel Nasal Airflow System on Sleep Quality & Perception
Scientific title
Comparison of nasal airflow via cannula vs nasal pressure via mask on sleep quality and perception in mild to moderate obstructive sleep apnoea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild or moderate obstructive sleep apnoea 2589 0
Condition category
Condition code
Respiratory 2700 2700 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Constant airflow administered via nasal cannual to deliver pharyngeal pressure <4 cm H20 for 8 hours during 1 night.
Intervention code [1] 2322 0
Treatment: Devices
Comparator / control treatment
Constant air pressure administered via nasal mask to deliver pharyngeal pressure >4 cm H2O for 8 hours during 1 night.
Control group
Active

Outcomes
Primary outcome [1] 3599 0
respiratory disturbance index
Timepoint [1] 3599 0
at baseline and immediately following intervention
Secondary outcome [1] 6025 0
arousal index
Timepoint [1] 6025 0
at baseline and immediately following intervention

Eligibility
Key inclusion criteria
apnoea hypopnoea index <30
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Other acute or chronic respiratory illness including but not limited to: Chronic obstructive pulmonary disease & asthma

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



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 501 0
6009

Funding & Sponsors
Funding source category [1] 2833 0
Self funded/Unfunded
Name [1] 2833 0
Country [1] 2833 0
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
NEDLANDS, WA 6009
Country
Australia
Secondary sponsor category [1] 2557 0
None
Name [1] 2557 0
Address [1] 2557 0
Country [1] 2557 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The study is being conducted to determine the effect of a novel treatment for sleep apnoea, using a nasal airflow cannula to raise phayngeal pressure. The outcomes assessed will be objective measures of sleep quality, as well as patient assessment of sleep quality. The treatment will be compared to CPAP, which is the current standard treatment for sleep apnoea.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28216 0
Address 28216 0
Country 28216 0
Phone 28216 0
Fax 28216 0
Email 28216 0
Contact person for public queries
Name 11373 0
Dr Jason Kirkness
Address 11373 0
Department of Pulmonary Physiology
Level 5, G Block
Sir Charles Gairdner
Country 11373 0
Australia
Phone 11373 0
(08) 9346 3154
Fax 11373 0
(08) 9346 2034
Email 11373 0
[email protected]
Contact person for scientific queries
Name 2301 0
Dr Jason Kirkness
Address 2301 0
Department of Pulmonary Physiology
Level 5, G Block
Sir Charles Gairdner
Country 2301 0
Australia
Phone 2301 0
(08) 9346 3154
Fax 2301 0
(08) 9346 2034
Email 2301 0
[email protected]

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.