Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000184370
Ethics application status
Approved
Date submitted
31/03/2008
Date registered
10/04/2008
Date last updated
6/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Auto positive airway pressure for obstructive sleep apnoea
Scientific title
Auto PAP: its effectiveness in reducing the apnoea hypopnoea index in severe obstructive sleep apnoea
Secondary ID [1] 283155 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Obstructive Sleep Apnoea 2977 0
Obstructive sleep apnoea 290012 0
Condition category
Condition code
Respiratory 3120 3120 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Crossover trial of AutoPAP and CPAP for a period of 4 nights with a 4 night washout
Intervention code [1] 2715 0
Treatment: Devices
Comparator / control treatment
Continuous Positive Airway Pressure (CPAP) for 4 nights
Control group
Active

Outcomes
Primary outcome [1] 4009 0
Apnoea Hypopnoea Index (events per hour) on treatment after 4 nights lead in
Timepoint [1] 4009 0
Each treatment will be used for 4 nights with the 4th night spent at the laboratory for monitoring and recording of end points
Secondary outcome [1] 6746 0
Augmentation index (measure of arterial stiffness) measured at the start and end of each treatment arm
Timepoint [1] 6746 0
Start end end of each arm- 4 nights

Eligibility
Key inclusion criteria
Patients with severe OSA and either BMI > 40kg/m2 or neck circumference> 48cm plus a need for a manually titrated CPAP pressure of >= 14cmH2O to prevent 95% of OSA
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Another sleep disorder
Cardiac or respiratory failure
Poor comprehension of English

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)
Subjects enrolled by Medical Director who ensures inclusion criteria met. They are not involved in randomisation. Randomisation is in an opaque envelope opened by the technician providing treatment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss determines order of randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2008
Actual
15/03/2008
Date of last participant enrolment
Anticipated
1/09/2008
Actual
1/11/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 850 0
New Zealand
State/province [1] 850 0
Wellington
Country [2] 851 0
New Zealand
State/province [2] 851 0

Funding & Sponsors
Funding source category [1] 3239 0
Charities/Societies/Foundations
Name [1] 3239 0
Asthma and Respiratory Foundation of NZ
Country [1] 3239 0
New Zealand
Funding source category [2] 3240 0
Charities/Societies/Foundations
Name [2] 3240 0
Asthma and Respiratory Foundation of NZ
Country [2] 3240 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
DUNEDIN
Leith St Dunedin
Country
New Zealand
Secondary sponsor category [1] 2897 0
University
Name [1] 2897 0
Research Administrator
Address [1] 2897 0
Otago University Wellington
PO Box 7343
Wellington South
Mein St Newtown Wellington
Country [1] 2897 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5220 0
Central Regional Ethics Committee
Ethics committee address [1] 5220 0
PO Box 5013
Wellington
Ethics committee country [1] 5220 0
New Zealand
Date submitted for ethics approval [1] 5220 0
01/09/2007
Approval date [1] 5220 0
14/09/2007
Ethics approval number [1] 5220 0
Ethics committee name [2] 5221 0
Central Regional Ethics Committee
Ethics committee address [2] 5221 0
PO Box 5013
Wellington
Ethics committee country [2] 5221 0
New Zealand
Date submitted for ethics approval [2] 5221 0
01/09/2007
Approval date [2] 5221 0
14/09/2007
Ethics approval number [2] 5221 0

Summary
Brief summary
Study aims to determine whether autoPAP technology is suitable for patients requiring a high treatment pressure to treat obstructive sleep apnoea. The study found that this was very variable with some patients being well treated and others not.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28477 0
A/Prof Alister Neill
Address 28477 0
Dept Medicine
University Otago Wellington
PO Box 7343
Wellington NZ
Country 28477 0
New Zealand
Phone 28477 0
+64 4 3855999
Fax 28477 0
Email 28477 0
[email protected]
Contact person for public queries
Name 11634 0
A/Prof Alister Neill
Address 11634 0
Department of Medicine
OUW
PO Box 7343
Wellington South
Country 11634 0
New Zealand
Phone 11634 0
+64 4 3855999
Fax 11634 0
Email 11634 0
[email protected]
Contact person for scientific queries
Name 2562 0
A/Prof Alister Neill
Address 2562 0
Department of Medicine
OUW
PO Box 7343
Wellington South
Country 2562 0
New Zealand
Phone 2562 0
+64 4 3855999
Fax 2562 0
Email 2562 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.