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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12615000896572 |
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Date of registration:
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27/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A prospective validation of a simplified Screening model of questionnaire and oximetry for detecting moderate to severe Obstructive Sleep Apnoea in chronic Tetraplegia. (SOSAT)
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Scientific title:
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A prospective validation of a simplified Screening model of questionnaire and oximetry for detecting moderate to severe Obstructive Sleep Apnoea in chronic Tetraplegia. (SOSAT) |
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Date of first enrolment:
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10/09/2015 |
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Target sample size:
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105 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12615000896572.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Canada
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United Kingdom
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Contacts
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Name:
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Ms Marnie Graco
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Address:
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Institute for Breathing and Sleep
The Austin Hospital
145 Studley Rd
Heidelberg 3084
Victoria
Australia |
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Telephone:
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+ 61 3 9496 3877 |
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Email:
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Marnie.Graco@austin.org.au |
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Affiliation:
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Name:
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Ms Marnie Graco
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Address:
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Institute for Breathing and Sleep
The Austin Hospital
145 Studley Rd
Heidelberg 3084
Victoria
Australia |
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Telephone:
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+ 61 3 9496 3877 |
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Email:
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Marnie.Graco@austin.org.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: - Chronic (at least 1 year since initial injury), traumatic tetraplegia (T1 lesion or higher).
- ASIA Impairment Scale A, B, C or D.
- Aged 18 and older
Exclusion criteria: - Currently being treated for OSA
- Current inpatient admission for a cardiorespiratory related complication
- Inability to give informed consent
- Medical instability
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Neurological - Other neurological disorders
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Obstructive Sleep Apnoea;
Obstructive Sleep Apnoea
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Injuries and Accidents - Other injuries and accidents
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Respiratory - Sleep apnoea
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Intervention(s)
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Diagnosis of obstructive sleep apnoea - the diagnostic test under evaluation is a two stage screening model of questionnaire and overnight oximetry. The OSA50 questionnaire is administered in the evening, followed by one overnight oximetry test, involving non-invasive sensor placed on the finger for the duration of the participant's sleep. The testing is performed in the participant's home or on the inpatient ward (if a current inpatient of the spinal unit).
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Primary Outcome(s)
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Accuracy of two stage screening model at detecting moderate to severe Obstructive Sleep Apnoea as assessed by comparison to the reference standard (polysomnography)[The questionnaire will be completed immediately prior to the overnight sleep study and overnight oximetry, which will both be simultaneously recording thoughout the night. ]
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Secondary Outcome(s)
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NA[NA]
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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Spinal Cord Injury Network
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Stoke-Mandeville Spinal Foundation
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Ethics review
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Status: Approved
Approval date:
Contact:
Austin Health
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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