Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000397516
Ethics application status
Approved
Date submitted
22/08/2006
Date registered
11/09/2006
Date last updated
8/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep Health in Tetraplegia-A population survey and home monitoring of sleep disordered breathing
Scientific title
Sleep Health in Tetraplegia-A cross sectional population survey and home monitoring of the prevalence of respiratory (especially Obstructive Sleep Apnoea) and other sleep disorders
Secondary ID [1] 288071 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tetraplegia 1363 0
Condition category
Condition code
Neurological 1456 1456 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
Sleep disturbances and disorders, particularly Sleep Apnoea will be assessed. The population survey using validated questionairres and the follow-up home monitoring with full polysomnography will be performed once each. The population survey takes 30-45 minutes and the home monitoring takes 12-18 hours to complete. The time interval between the questionairre completion and the full polysomnography performed in the home will typically be between 2 and 10 months. The entire study will take 18 months to complete.
Intervention code [1] 1321 0
Diagnosis / Prognosis
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2008 0
Sleep apnoea prevalence, estimated with the questionnaires and confirmed with follow-up home sleep studies
Timepoint [1] 2008 0
Estimated once only using questionairre responses and confirmed once only with home polysomnography
Secondary outcome [1] 3477 0
Nordic Sleep Questionnaire
Timepoint [1] 3477 0
Measures made at baseline only
Secondary outcome [2] 3478 0
Karolinska Sleepiness Scale - a ten item scale which describes current (state) sleepiness.
Timepoint [2] 3478 0
Measures made at baseline only
Secondary outcome [3] 3479 0
Apnoea Prediction Equation (MAPI)- gives a likelihood of OSA as defined by a Respiratory Disturbance Index (RDI)
Timepoint [3] 3479 0
Measures made at baseline only
Secondary outcome [4] 3480 0
Functional Outcomes of Sleep Questionnaire (FOSQ) - measures impact of sleep on daily activity
Timepoint [4] 3480 0
Measures made at baseline only
Secondary outcome [5] 3481 0
Generic quality of life tool (AQoL)
Timepoint [5] 3481 0
Measures made at baseline only

Eligibility
Key inclusion criteria
Tetraplegia, ie lesion level higher than T1 on hospital discharge.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not currently resident in Victoria.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/09/2006
Actual
11/09/2006
Date of last participant enrolment
Anticipated
11/09/2006
Actual
11/09/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
113
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 1593 0
Government body
Name [1] 1593 0
Victorian Neurotrauma Initiative
Country [1] 1593 0
Australia
Primary sponsor type
Other
Name
Victorian Neurotrauma Initiative
Address
222 Exhibition St, Melbourne 3000 Vic
Country
Australia
Secondary sponsor category [1] 1399 0
Other
Name [1] 1399 0
Institute for breathing and sleep. Austin Health, Victoria
Address [1] 1399 0
Institute for Breathing and Sleep Austin Hospital Studley Rd Heidelberg VIC 3084
Country [1] 1399 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3017 0
Austin Health
Ethics committee address [1] 3017 0
Ethics committee country [1] 3017 0
Australia
Date submitted for ethics approval [1] 3017 0
Approval date [1] 3017 0
24/08/2006
Ethics approval number [1] 3017 0
02591

Summary
Brief summary
Spinal cord injury (SCI) is one of the most catastrophic disabilities to afflict man. The paralysis is permanent and the disability severe. There is emerging, compelling evidence that tetraplegia, the loss of function in both arms and legs, results in greater secondary disability due to disturbed sleep and breathing overnight. This study aims to comprehensively evaluate sleep health in tetraplegia by documenting sleep disturbances and determining the prevalence and nature of any sleep disordered breathing (SDB) in the Victorian population with tetraplegia. Over 18 months we propose to gain questionnaire responses from people with tetraplegia in Victoria regarding the frequency, nature and severity of any sleep disturbances they may experience. Additionally, we will perform full sleep studies at home on those with more severe injuries. The project will produce a comprehensive description of the tetraplegic population in Victoria, it will identify the nature and prevalence of sleep disturbances in this population, it will characterise sleep quality and will establish the prevalence of Obstructive Sleep Apnoea (OSA) and other forms of SDB in this group. It is known that OSA and sleep disturbances are significantly under diagnosed in people with SCI and this project is likely have an immediate, positive impact for the participants as problems are diagnosed and treatments offered. Any reduction in disability will have immediate benefits for the individuals involved and will reduce the cost to the community for these profoundly disabled people.
Trial website
Trial related presentations / publications
Spong J, Graco M, Brown DJ, Schembri R, Berlowitz DJ. Subjective sleep disturbances and quality of life in chronic tetraplegia. Spinal Cord 2015 56: 636-640

Berlowitz DJ, Spong J, Gordon I, Howard ME, Brown DJ. Relationships between objective sleep indices and symptoms in a community sample of people with tetraplegia. Archives of Physical Medicine and Rehabilitation. 2012. 93(7): 1246-52.
Public notes

Contacts
Principal investigator
Name 27928 0
A/Prof David Berlowitz
Address 27928 0
Bowen Centre. Austin Health, PO Box 5555. heiedlberg 3084
Country 27928 0
Australia
Phone 27928 0
+61394963871
Fax 27928 0
Email 27928 0
[email protected]
Contact person for public queries
Name 10510 0
A/Prof David Berlowitz
Address 10510 0
Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidleberg VIC 3084
Country 10510 0
Australia
Phone 10510 0
+61 3 94963688
Fax 10510 0
Email 10510 0
[email protected]
Contact person for scientific queries
Name 1438 0
A/Prof David Berlowitz
Address 1438 0
Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidleberg VIC 3084
Country 1438 0
Australia
Phone 1438 0
+61 3 94963688
Fax 1438 0
Email 1438 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
SourceTitleYear of PublicationDOI
EmbaseSubjective sleep disturbances and quality of life in chronic tetraplegia.2015https://dx.doi.org/10.1038/sc.2015.68
N.B. These documents automatically identified may not have been verified by the study sponsor.