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Trial registered on ANZCTR


Registration number
ACTRN12615000896572
Ethics application status
Approved
Date submitted
24/06/2015
Date registered
27/08/2015
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective validation of a simplified Screening model of questionnaire and oximetry for detecting moderate to severe Obstructive Sleep Apnoea in chronic Tetraplegia. (SOSAT)
Scientific title
A prospective validation of a simplified Screening model of questionnaire and oximetry for detecting moderate to severe Obstructive Sleep Apnoea in chronic Tetraplegia. (SOSAT)
Secondary ID [1] 286942 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SOSAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 295371 0
Condition category
Condition code
Neurological 295636 295636 0 0
Other neurological disorders
Respiratory 295776 295776 0 0
Sleep apnoea
Injuries and Accidents 295777 295777 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 292133 0
Diagnosis / Prognosis
Intervention code [2] 292134 0
Early detection / Screening
Comparator / control treatment
Full overnight polysomnography is the comparator test. The sleep study will be performed using a portable sleep monitoring device which comprehensively measures respiratory and sleep variables. (Compumedics TM SomtePSG, Abbottsford, Australia). This measures EEG, EOG, EMG (mentalis and diaphragm), ECG, respiratory motion, nasal pressure, oral thermistor, arterial oxygen saturation, snoring and body position. The comparator test will be administered on the same night as the two stage screening model described above (questionnaire and oximetry).
Control group
Active

Outcomes
Primary outcome [1] 295354 0
Accuracy of two stage screening model at detecting moderate to severe Obstructive Sleep Apnoea as assessed by comparison to the reference standard (polysomnography)
Timepoint [1] 295354 0
The questionnaire will be completed immediately prior to the overnight sleep study and overnight oximetry, which will both be simultaneously recording thoughout the night.
Secondary outcome [1] 315403 0
NA
Timepoint [1] 315403 0
NA

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Currently being treated for OSA
- Current inpatient admission for a cardiorespiratory related complication
- Inability to give informed consent
- Medical instability

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants undergo testing with screening method under investigation (questionnaire and overnight oximetry)and the comparator method (full overnight polysomnography).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Both the screening method under investigation (questionnaire and overnight oximetry)and the comparator method (full overnight polysomnography) are completed at the same time in all participants. Therefore there is no randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
ROC curve analysis of the questionnaires and 3%ODI to assess the ability of the two stages to discriminate moderate to severe OSA in tetraplegia. Sensitivity and specificity, positive and negative predictive values, positive and negative likelihood values and overall test accuracy will be calculated for the two-stage model as a whole.

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3949 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 9860 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 6985 0
United Kingdom
State/province [1] 6985 0
Country [2] 6986 0
Canada
State/province [2] 6986 0
British Columbia

Funding & Sponsors
Funding source category [1] 291517 0
Charities/Societies/Foundations
Name [1] 291517 0
Spinal Cord Injury Network
Address [1] 291517 0
Newtown Business Centre,
Suite 104, 1 Erskineville Rd,
Newtown NSW 2042, Australia
Country [1] 291517 0
Australia
Funding source category [2] 291518 0
Charities/Societies/Foundations
Name [2] 291518 0
Stoke-Mandeville Spinal Foundation
Address [2] 291518 0
Aylesbury
Buckinghamshire
HP21 8AL
Country [2] 291518 0
United Kingdom
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Breathing and Sleep
Address
The Austin Hospital
145 Studley Rd
Heidelberg 3084
Victoria
Country
Australia
Secondary sponsor category [1] 290199 0
Hospital
Name [1] 290199 0
Stoke-Mandeville Hospital, Buckinghamshire Healthcare
Address [1] 290199 0
Aylesbury
Buckinghamshire
HP21 8AL
Country [1] 290199 0
United Kingdom
Secondary sponsor category [2] 290200 0
Hospital
Name [2] 290200 0
GF Strong Rehabilitation Centre
Address [2] 290200 0
4255 Laurel St, Vancouver, BC V5Z 2G9
Country [2] 290200 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293060 0
Austin Health
Ethics committee address [1] 293060 0
The Austin Hospital
145 Studley Rd
Heidelberg 3084
Victoria
Ethics committee country [1] 293060 0
Australia
Date submitted for ethics approval [1] 293060 0
01/07/2015
Approval date [1] 293060 0
17/08/2015
Ethics approval number [1] 293060 0

Summary
Brief summary
Approximately 50% of people with tetraplegia have obstructive sleep apnoea (OSA), which is a direct consequence of their injury. OSA has been linked to poor quality of life and problems with memory, learning and concentration in people with tetraplegia. Current guidelines recommend that all people with tetraplegia and symptoms of sleepiness undergo a full sleep study (polysomnography) to diagnose OSA or not. However, very few spinal units have access to this expensive and highly specialised equipment, a sleep scientist to perform the test and a sleep physician to understand and communicate the results. It is therefore likely that most people with tetraplegia and OSA are undiagnosed and untreated.
This project aims to test whether a questionnaire followed by overnight oximetry (a finger probe that measures the oxygen level of the blood) can accurately detect moderate to severe OSA in people with tetraplegia. If successful, this simple screening test could replace the need for a full sleep study. Improving the diagnosis of this condition will enable many people with tetraplegia and OSA to access treatment for their condition with likely improvement in their quality of life.
Trial website
NA
Trial related presentations / publications
NA
Public notes
NA

Contacts
Principal investigator
Name 58202 0
Dr David Berlowitz
Address 58202 0
Institute for Breathing and Sleep
The Austin Hospital
145 Studley Rd
Heidelberg 3084
Victoria
Country 58202 0
Australia
Phone 58202 0
+61 3 9496 3871
Fax 58202 0
Email 58202 0
David.Berlowitz@austin.org.au
Contact person for public queries
Name 58203 0
Ms Marnie Graco
Address 58203 0
Institute for Breathing and Sleep
The Austin Hospital
145 Studley Rd
Heidelberg 3084
Victoria
Country 58203 0
Australia
Phone 58203 0
+ 61 3 9496 3877
Fax 58203 0
Email 58203 0
Marnie.Graco@austin.org.au
Contact person for scientific queries
Name 58204 0
Ms Marnie Graco
Address 58204 0
Institute for Breathing and Sleep
The Austin Hospital
145 Studley Rd
Heidelberg 3084
Victoria
Country 58204 0
Australia
Phone 58204 0
+ 61 3 9496 3877
Fax 58204 0
Email 58204 0
Marnie.Graco@austin.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary