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Trial registered on ANZCTR


Registration number
ACTRN12605000326695
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
7/09/2005
Date last updated
4/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of an antisupine device in the management of positional OSA
Scientific title
The effectiveness of controlled sleep position versus nCPAP in the management of positional obstructive sleep apnoea.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 414 0
Condition category
Condition code
Respiratory 485 485 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A thoracic antisupine device with novel design features will be worn during sleep. At the end of one month a home-based overnight sleep study with the device in situ will be performed. After a one week washout, followed by a month on nCPAP the study will be repeated.
Intervention code [1] 311 0
Treatment: Devices
Comparator / control treatment
Use of the thoracic anti supine band (TASB) nightly for one month was compared with standard treatment nasal continuous positive airway pressure (nCPAP) for the alternate month;
Control group
Uncontrolled

Outcomes
Primary outcome [1] 556 0
Apnoea hypopnoea index reduced to clinically acceptable levels (</= 10/h) as measured by the home sleep study and relief of symptoms such as daytime hyersomnolence
Timepoint [1] 556 0
At the end of the month on the device.
Secondary outcome [1] 1178 0
An overnight sleep study will be performed. Analysis of data will include the period of time spent sleeping in the supine posture. (Success with the anti-supine device <10% sleep in supine).
Timepoint [1] 1178 0
At the end of the one month period.

Eligibility
Key inclusion criteria
Adults with positional obstructive sleep apnoea (OSA) with at least 10% of sleep in supine and apnoea hypopnoea index (AHI) twice as much in supine and non supine.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other co-morbidities interefering with sleep.

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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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 outside Australia
Country [1] 155 0
New Zealand
State/province [1] 155 0

Funding & Sponsors
Funding source category [1] 551 0
Charities/Societies/Foundations
Name [1] 551 0
Respiratory Research Trust
Address [1] 551 0
c/o Respiratory Research Dept School of Medical and Surgical Sciences Dunedin School of Medicine University of Otago P O Box 913 Dunedin
Country [1] 551 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
School of Physiotherapy
University of Otago
325 Great King Street
Dunedin
Country
New Zealand
Secondary sponsor category [1] 445 0
None
Name [1] 445 0
N/A
Address [1] 445 0
Country [1] 445 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1563 0
National Ethics Committee Lower South Region
Ethics committee address [1] 1563 0
P O Box 5849 Dunedin New Zealand
Ethics committee country [1] 1563 0
New Zealand
Date submitted for ethics approval [1] 1563 0
Approval date [1] 1563 0
23/10/2005
Ethics approval number [1] 1563 0

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

Contacts
Principal investigator
Name 35800 0
Address 35800 0
Country 35800 0
Phone 35800 0
Fax 35800 0
Email 35800 0
Contact person for public queries
Name 9500 0
Professor D Robin Taylor
Address 9500 0
Respiratory Research Unit
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
Country 9500 0
New Zealand
Phone 9500 0
+64 3 4740999 (Ext. 8785)
Fax 9500 0
Email 9500 0
robin.taylor@stonebow.otago.ac.nz
Contact person for scientific queries
Name 428 0
Dr Margot Skinner
Address 428 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin
Country 428 0
New Zealand
Phone 428 0
+64 3 4797466
Fax 428 0
Email 428 0
margot.skinner@otago.ac.nz

No data has been provided for results reporting
'Other' documents specified
Data contained in the publication listed.
Summary results
Not applicable