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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000746639
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
16/11/2005
Date last updated
16/11/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of long term nocturnal bi-level ventilatory support on gas exchange in stable but severe respiratory disease due to cystic fibrosis.
Scientific title
The effects of long term nocturnal bi-level ventilatory support on gas exchange in stable but severe respiratory disease due to cystic fibrosis.
Universal Trial Number (UTN)
Trial acronym
Not applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 898 0
Condition category
Condition code
Human Genetics and Inherited Disorders 966 966 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective uncontrolled observational study evaluating the effects of nocturnal bi-level ventilatory support on lung function tests, ABG and detailed gas exchange measured by MIGET (multiple inert gas elimination technique) over a three to six month treatment duration.
Intervention code [1] 633 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1282 0
The effects of bi-level ventilation on spirometry gas exchange
Timepoint [1] 1282 0
After three to six months whilst in a clinically stable state.
Primary outcome [2] 1283 0
The effects of bi-level ventilation on ABG gas exchange
Timepoint [2] 1283 0
After three to six months whilst in a clinically stable state.
Primary outcome [3] 1284 0
The effects of bi-level ventilation on MIGET gas exchange
Timepoint [3] 1284 0
After three to six months whilst in a clinically stable state.
Secondary outcome [1] 2310 0
Not applicable
Timepoint [1] 2310 0

Eligibility
Key inclusion criteria
A diagnosis of cystic fibrosis, stable state. Known sleep disordered breathing on the basis of polysomnography with desaturation.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable cystic fibrosis.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1064 0
Government body
Name [1] 1064 0
Australian NHMRC personal scholarship
Address [1] 1064 0
Country [1] 1064 0
Australia
Primary sponsor type
Government body
Name
Australian NHMRC personal scholarship
Address
Country
Australia
Secondary sponsor category [1] 926 0
None
Name [1] 926 0
Not applicable
Address [1] 926 0
Country [1] 926 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2366 0
Central Sydney Area Health Service Ethics Committee
Ethics committee address [1] 2366 0
Ethics committee country [1] 2366 0
Australia
Date submitted for ethics approval [1] 2366 0
Approval date [1] 2366 0
Ethics approval number [1] 2366 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35712 0
Address 35712 0
Country 35712 0
Phone 35712 0
Fax 35712 0
Email 35712 0
Contact person for public queries
Name 9822 0
Ms Sarah Newton-John
Address 9822 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9822 0
Australia
Phone 9822 0
+61 2 95156578
Fax 9822 0
+61 2 95505865
Email 9822 0
wtaylor@woolcock.org.au
Contact person for scientific queries
Name 750 0
Dr Rajeev Soni
Address 750 0
PO Box 361
Gosford NSW 2250
Country 750 0
Australia
Phone 750 0
+61 2 43202792
Fax 750 0
+61 2 43202042
Email 750 0
rsoni@nsccahs.health.gov.nsw.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary