Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000159550
Ethics application status
Approved
Date submitted
4/05/2006
Date registered
4/05/2006
Date last updated
8/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of Continuous Positive Airway Pressure (CPAP) treatment for sleep disordered breathing in acute tetraplegia
Scientific title
The feasibility of Continuous Positive Airway Pressure (CPAP) treatment for sleep disordered breathing in acute tetraplegia
Secondary ID [1] 288092 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea (OSA) in acute tetraplegia 1132 0
Condition category
Condition code
Respiratory 1210 1210 0 0
Sleep apnoea
Neurological 1211 1211 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Three months trial of Continuous Positive Airway Pressure (CPAP) treatment for OSA in tetraplegia
Intervention code [1] 1019 0
None
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1641 0
Effectiveness of change in oxygen desaturation rate
Timepoint [1] 1641 0
Measurements of effectiveness will be made at baseline and after 3 months
Primary outcome [2] 1642 0
Adherence to therapy
Timepoint [2] 1642 0
Adherence will be monitored daily and recorded weekly
Secondary outcome [1] 2938 0
The amount and nature of the assistance required to maximise CPAP uptake will be examined to determine what proportion of subjects required what amount of support.
Timepoint [1] 2938 0
These measures will be made daily and recorded weekly.

Eligibility
Key inclusion criteria
Acute tetraplegia. All American Spinal Injury Association (ASIA) classifications and lesion levels will be included.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Admission, physician diagnosis of significant head injury, significant pre-existing respiratory or cardiac disease and any other significant co-morbidity. An inability of provide informed consent. Planned hospital discharge within six weeks.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2006
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
1/10/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 1323 0
Other
Name [1] 1323 0
Institute for breathing and sleep
Country [1] 1323 0
Australia
Primary sponsor type
Other
Name
Institute for breathing and sleep
Address
Institute for Breathing and Sleep Austin Hospital Studley Rd Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 1168 0
None
Name [1] 1168 0
Nil
Address [1] 1168 0
Country [1] 1168 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293994 0
Austin Heath Human Ethics
Ethics committee address [1] 293994 0
Austin Health
Studley Rd
Heidelberg 3084
Vic
Ethics committee country [1] 293994 0
Australia
Date submitted for ethics approval [1] 293994 0
Approval date [1] 293994 0
13/04/2006
Ethics approval number [1] 293994 0
H2006/02543

Summary
Brief summary
This study is designed to examine the feasibility of Continuous Positive Airway Pressure (CPAP) treatment for Obstructive Sleep Apnoea (OSA) in acute tetraplegia. This pilot study will examine how well CPAP is tolerated and if treatment is feasible prior to the commencement of any randomised, controlled trial of therapy.
Trial website
Trial related presentations / publications
Berlowitz DJ, Spong J, Pierce RJ, Ross J, Barnes M & Brown DJ. The feasibility of using auto-titrating continuous positive airway pressure to treat obstructive sleep apnoea after acute tetraplegia. Spinal Cord 2009 47: 868-873.
Public notes

Contacts
Principal investigator
Name 35543 0
A/Prof David Berlowitz
Address 35543 0
Bowen Centre. Austin Health
Studley Rd Heidelberg 3084
Vic
Country 35543 0
Australia
Phone 35543 0
+61394963871
Fax 35543 0
Email 35543 0
[email protected]
Contact person for public queries
Name 10208 0
A/Prof David Berlowitz
Address 10208 0
Institute for Breathing and Sleep
Austin Hospital
Studley Rd Heidelberg VIC 3084
Country 10208 0
Australia
Phone 10208 0
+61 3 94963688
Fax 10208 0
Email 10208 0
[email protected]
Contact person for scientific queries
Name 1136 0
A/Prof David Berlowitz
Address 1136 0
Institute for Breathing and Sleep
Austin Hospital
Studley Rd Heidelberg VIC 3084
Country 1136 0
Australia
Phone 1136 0
+61 3 94963688
Fax 1136 0
Email 1136 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.