ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Tetraplegia

Condition category

Condition code

Neurological

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]

Diagnosis / Prognosis

Comparator / control treatment

No comparator.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Sleep apnoea prevalence, estimated with the questionnaires and confirmed with follow-up home sleep studies

Timepoint [1]

Estimated once only using questionairre responses and confirmed once only with home polysomnography

Secondary outcome [1]

Nordic Sleep Questionnaire

Timepoint [1]

Measures made at baseline only

Secondary outcome [2]

Karolinska Sleepiness Scale - a ten item scale which describes current (state) sleepiness.

Timepoint [2]

Measures made at baseline only

Secondary outcome [3]

Apnoea Prediction Equation (MAPI)- gives a likelihood of OSA as defined by a Respiratory Disturbance Index (RDI)

Timepoint [3]

Measures made at baseline only

Secondary outcome [4]

Functional Outcomes of Sleep Questionnaire (FOSQ) - measures impact of sleep on daily activity

Timepoint [4]

Measures made at baseline only

Secondary outcome [5]

Generic quality of life tool (AQoL)

Timepoint [5]

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]

Government body

Name [1]

Victorian Neurotrauma Initiative

Address [1]

Exhibition St, Melbourne 3000

Country [1]

Australia

Primary sponsor type

Other

Name

Victorian Neurotrauma Initiative

Address

222 Exhibition St, Melbourne 3000 Vic

Country

Australia

Secondary sponsor category [1]

Other

Name [1]

Institute for breathing and sleep. Austin Health, Victoria

Address [1]

Institute for Breathing and Sleep Austin Hospital Studley Rd Heidelberg VIC 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/08/2006

Ethics approval number [1]

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

A/Prof David Berlowitz

Address

Bowen Centre. Austin Health, PO Box 5555. heiedlberg 3084

Country

Australia

Phone

+61394963871

Fax

Email

david.berlowitz@austin.org.au

Contact person for public queries

Name

David Berlowitz

Address

Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidleberg VIC 3084

Country

Australia

Phone

+61 3 94963688

Fax

Email

david.berlowitz@austin.org.au

Contact person for scientific queries

Name

David Berlowitz

Address

Institute for Breathing and Sleep
Austin Health
Studley Rd
Heidleberg VIC 3084

Country

Australia

Phone

+61 3 94963688

Fax

Email

david.berlowitz@austin.org.au

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

Source	Title	Year of Publication	DOI
Embase	Subjective sleep disturbances and quality of life in chronic tetraplegia.	2015	https://dx.doi.org/10.1038/sc.2015.68

N.B. These documents automatically identified may not have been verified by the study sponsor.