Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000420640
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
18/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised 12 month trial of Non-Invasive Ventilation (NIV) with or without oxygen versus oxygen alone in treatment of sleep disordered breathing in Cystic Fibrosis
Scientific title
Randomised 12 month trial of Non-Invasive Ventilation (NIV) with or without oxygen versus oxygen alone in treatment of sleep disordered breathing in Cystic Fibrosis
Secondary ID [1] 287926 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 529 0
Condition category
Condition code
Human Genetics and Inherited Disorders 609 609 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised to oxygen alone or NIV with or without oxygen, as titrated during polysomnography to maintain oxygen saturation >=90% in all sleep stages. Patients will be followed-up over 12 months. Repeat sleep studies at 3, 6 and 12 months. They will be censored if they undergo lung transplant or die. They cease the trial if defined as a 'treatment failure'
Intervention code [1] 496 0
Treatment: Devices
Comparator / control treatment
Control group was oxygen alone
Control group
Active

Outcomes
Primary outcome [1] 709 0
Number of treatment failures (PaCO2>60 or an increase >10mmHg from baseline; or increase TcCO2>10 from awake to sleep).
Timepoint [1] 709 0
This is time-to-event data, so "treatment failure" will be recorded if it occurs any time from baseline (day 0) within the 12 month time frame of the study.
Primary outcome [2] 710 0
Change in daytime PaCO2 from baseline to 12 months.
Timepoint [2] 710 0
12 months
Secondary outcome [1] 1467 0
Quality of life
Timepoint [1] 1467 0
Baseline, 3 months, 6 months, 12 months
Secondary outcome [2] 1468 0
Sleep quality
Timepoint [2] 1468 0
Baseline, 3 months, 6 months, 12 months
Secondary outcome [3] 1469 0
Lung function
Timepoint [3] 1469 0
Baseline, 3 months, 6 months, 12 months
Secondary outcome [4] 1470 0
Days on IV antibiotics
Timepoint [4] 1470 0
Total days on IV antibiotics within the 12 month study
Secondary outcome [5] 1471 0
Days in hospital (excluding trial measurement days)
Timepoint [5] 1471 0
Total days in hospital (excluding trial measurement days) within the 12 month study
Secondary outcome [6] 1472 0
Direct medical costs
Timepoint [6] 1472 0
Total direct medical costs within the 12 month study

Eligibility
Key inclusion criteria
Stable CF adults with total sleep time minimum average oxygen saturation <=90%
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute unstable hypercapnic respiratory failure (PaCO2>60; eligible for randomisation after acute treatment if stable off NIV for a minimum of two weeks); severe co-existing disease; persistent pneumothoraces; sputum colonised with burkolderia cepacia.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation table. Block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/1998
Actual
11/06/1998
Date of last participant enrolment
Anticipated
Actual
16/04/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 665 0
Government body
Name [1] 665 0
NHMRC Progress Grant
Country [1] 665 0
Australia
Primary sponsor type
Government body
Name
SWSAHS
Address
Level 11, KGV Building
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 555 0
None
Name [1] 555 0
None
Address [1] 555 0
Country [1] 555 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1846 0
Royal Prince Alfred Hospital
Ethics committee address [1] 1846 0
Ethics committee country [1] 1846 0
Australia
Date submitted for ethics approval [1] 1846 0
Approval date [1] 1846 0
29/05/1998
Ethics approval number [1] 1846 0
Ethics committee name [2] 1847 0
Prince Charles Hospital
Ethics committee address [2] 1847 0
Ethics committee country [2] 1847 0
Australia
Date submitted for ethics approval [2] 1847 0
Approval date [2] 1847 0
21/11/2002
Ethics approval number [2] 1847 0

Summary
Brief summary
Last participant recruited 16/4/2010. Recruitment halted 2015 as no participant recruited in last 5 years. Data analysis ongoing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35699 0
Prof Peter Bye
Address 35699 0
Respiratory Medicine
Level 11
RPA Hospital
Missenden Road
Camperdown NSW 2050
Country 35699 0
Australia
Phone 35699 0
+61 2 9515 7427
Fax 35699 0
Email 35699 0
peter.bye@sydney.edu.au
Contact person for public queries
Name 9685 0
Dr Tiffany Dwyer
Address 9685 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
11 West
Missenden Road
Camperdown NSW 2050
Country 9685 0
Australia
Phone 9685 0
+61 2 95155234
Fax 9685 0
+61 2 95158196
Email 9685 0
tiffany.dwyer@sydney.edu.au
Contact person for scientific queries
Name 613 0
Prof Peter Bye
Address 613 0
Department of Respiratory Medicine
Royal Prince Alfred Hospital
11 West
Missenden Road
Camperdown NSW 2050
Country 613 0
Australia
Phone 613 0
+61 2 95157427
Fax 613 0
+61 2 95158196
Email 613 0
peter.bye@sydney.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.