Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000359437
Ethics application status
Approved
Date submitted
4/07/2007
Date registered
4/07/2007
Date last updated
6/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Double blind parallel trial of Continuous Positive Airway Pressure versus CFLEX-a form of CPAP with exhalation pressure reduction: Effects on objective compliance, reaction time and objective alertness in patients with obstructive sleep apnoea
Scientific title
Double blind parallel trial of Continuous Positive Airway Pressure versus CFLEX-a form of CPAP with exhalation pressure reduction: Effects on objective compliance, reaction time and objective alertness in patients with obstructive sleep apnoea
Secondary ID [1] 283158 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 1916 0
Condition category
Condition code
Respiratory 2007 2007 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuous positive airway pressure (CPAP- control ) versus C-FLEX -a form of CPAP with exhalation pressure reduction (intervention). The subjects will use the treatment over a 3 month period each time they sleep.
Intervention code [1] 1871 0
Treatment: Devices
Comparator / control treatment
Standard CPAP
Control group
Active

Outcomes
Primary outcome [1] 2834 0
Objective compliance in average hours per night
Timepoint [1] 2834 0
Measured at 3 months
Secondary outcome [1] 4781 0
Patient preference by questionnaire at the end of the trial
Timepoint [1] 4781 0
3 months

Eligibility
Key inclusion criteria
Adults (males and females) with polysomnographically confirmed obstructive sleep apnoea with an apnoea hypopnoea index of > 30 or >20 plus severe daytime sleepiness. Written and oral english language comprehension.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of another sleep disorderSignificant co-morbidityUpper airway surgery since diagnostic study.

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)
Allocation to treatment was done immediately prior to CPAP titration study by the laboratory technician from sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of allocation was performed by simple randomisation using a urn with a 2, 1 schedule. This involved removing a piece of paper from a closed urn. There were two pieces of paper one which said 1=CPAP and the other 2=CFLEX, the paper was then returned to the urn for the next draw , and hence the sequence of intervention was generated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects and assessor/data analyst are blinded to treatment allocation in this study
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
Actual
1/03/2007
Date of last participant enrolment
Anticipated
1/03/2008
Actual
15/09/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment outside Australia
Country [1] 5394 0
New Zealand
State/province [1] 5394 0

Funding & Sponsors
Funding source category [1] 2151 0
Commercial sector/Industry
Name [1] 2151 0
Respironics Inc
Country [1] 2151 0
United States of America
Primary sponsor type
University
Name
Research and Enterprise, Otago University
Address
PO Box 56
Dunedin
Country
New Zealand
Secondary sponsor category [1] 1952 0
Individual
Name [1] 1952 0
Alister Neill, University of Otago, Wellington
Address [1] 1952 0
PO Box 56
Dunedin
Country [1] 1952 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3945 0
WellSleep Bowen Hospital
Ethics committee address [1] 3945 0
Ethics committee country [1] 3945 0
New Zealand
Date submitted for ethics approval [1] 3945 0
Approval date [1] 3945 0
06/12/2006
Ethics approval number [1] 3945 0
CFN06/04/033

Summary
Brief summary
The aim of the study is to determine whether CFLEX, a type of CPAP treatment with exhalation pressure reduction, is used more by patients with obstructive sleep apnoea than standard CPAP.
The hypothesis of the study is that CFLEX will be used on average more than CPAP over a 3 month period in patients with obstructive sleep apnoea.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27685 0
A/Prof Alister Neill
Address 27685 0
Dept Medicine
UOW
PO Box 7343
Wellington NZ
Country 27685 0
New Zealand
Phone 27685 0
+ 64 4 3855999
Fax 27685 0
Email 27685 0
[email protected]
Contact person for public queries
Name 11060 0
A/Prof Dr Alister Neill
Address 11060 0
Department of Medicine
Otago University Wellington
PO Box 7343
Wellington
Country 11060 0
New Zealand
Phone 11060 0
+64 4 3855999
Fax 11060 0
Email 11060 0
[email protected]
Contact person for scientific queries
Name 1988 0
A/Prof Dr Alister Neill
Address 1988 0
Department of Medicine
Otago University Wellington
PO Box 7343
Wellington
Country 1988 0
New Zealand
Phone 1988 0
+64 4 3855999
Fax 1988 0
Email 1988 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.