Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000274471
Ethics application status
Approved
Date submitted
8/03/2007
Date registered
22/05/2007
Date last updated
7/07/2022
Date data sharing statement initially provided
7/07/2022
Date results information initially provided
7/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Diagnosis of Obstructive Sleep Apnoea in primary Care
Scientific title
The effectiveness of a primary care disease detection program in the identification of Obstructive Sleep Apnoea (OSA)
Secondary ID [1] 253476 0
The Diagnosis of Obstructive Sleep Apnoea in primary Care, preliminary study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 1814 0
Condition category
Condition code
Respiratory 1904 1904 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Primary Care physicians will identify patients who satisfy the inclusion criteria and will administer questionnaires and refer to the research team or the practice nurse for assessment of upper airway function, other anthropometric instruments, and allocation of a single channel home based sleep apnoea monitoring device ( Flow Wizard, DiagnoseIT, Australia) and in hospital polysomnography in random order. Subjects will receive both polysomnography and home testing within a four week period. The questionnaires and anthropometric instruments as well as upper airway function using the Forced Oscillation Technique will be administered over 30 minutes by research staff upon enrolment. The in hospital polysomnography will be performed on a single night and the home based study will be performed over three nights at home.
Intervention code [1] 1639 0
Not applicable
Comparator / control treatment
Not applicable - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2710 0
To validate a diagnostic algorithm that would combine information from questionnaire, biometric clinical data, upper airway function and the results from a portable diagnostic device for use in the primary care setting.
Timepoint [1] 2710 0
Determined at the conclusion of the trial.
Secondary outcome [1] 4575 0
To examine the utility of the above algorithm in different patient subgroups for example according to sex, ethnicity, different disease groups such as cardiac and respiratory disease.
Timepoint [1] 4575 0
This will be determined at the conclusion of the trial.

Eligibility
Key inclusion criteria
Subjects have symptoms of sleep apnoea (including snoring, choking, witnessed apneas and daytime sleepiness) and/or co morbidities including obesity, hypertension and the metabolic syndrome.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects are unable to comply with procedures, unable to apply the diagnostic device (either by patient or other care-giver), or the diagnosis being considered is primarily a non-OSA sleep disorder such as insomnia, parasomnia or narcolepsy.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/02/2007
Actual
8/02/2007
Date of last participant enrolment
Anticipated
Actual
1/11/2007
Date of last data collection
Anticipated
Actual
30/11/2007
Sample size
Target
360
Accrual to date
Final
193
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 3591 0
2050

Funding & Sponsors
Funding source category [1] 2050 0
University
Name [1] 2050 0
University of Sydney Bridging Support Grant 2007
Country [1] 2050 0
Australia
Primary sponsor type
Other
Name
The Woolcock Institute of Medical Research
Address
PO Box M77
Missenden Road, NSW 2050
Country
Australia
Secondary sponsor category [1] 1858 0
University
Name [1] 1858 0
The University of Sydney
Address [1] 1858 0
University of Sydney, NSW 2006
Country [1] 1858 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3806 0
The University of Sydney
Ethics committee address [1] 3806 0
Level 3, Michael Spence Building (F23) University of Sydney NSW 2006
Ethics committee country [1] 3806 0
Australia
Date submitted for ethics approval [1] 3806 0
Approval date [1] 3806 0
01/02/2007
Ethics approval number [1] 3806 0
02-2007/9702

Summary
Brief summary
Subjects presenting to the general practitioner (GP) with suspected or possible sleep apnea will be asked to participate, and undergo the components of the index test (questionnaire instruments, anthropometric testing and the home based portable monitor) and the reference standard in-laboratory polysomnogram in random order. All tests will be performed within a 4 week period. The results will not be communicated to the participant or the treating physicians until all components have been performed. The participants will then be referred to a sleep specialist to have the results of the polysomnogram discussed, and appropriate management instituted outside of the study, as dictated by usual clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27573 0
Dr Lydia Makarie Rofail
Address 27573 0
Woolcock Institute of Medical Research PO Box M77 Missenden Rd Camperdown NSW 2050
Country 27573 0
Australia
Phone 27573 0
+61 2 95157590
Fax 27573 0
Email 27573 0
[email protected]
Contact person for public queries
Name 10828 0
Ms Sarah Newton-John
Address 10828 0
Woolcock Institute of Medical Research
PO Box M77 Missenden Rd
Camperdown NSW 2050
Country 10828 0
Australia
Phone 10828 0
+61 2 95156578
Fax 10828 0
+61 2 95505865
Email 10828 0
[email protected]
Contact person for scientific queries
Name 1756 0
Dr Lydia Makarie Rofail
Address 1756 0
Woolcock Institute of Medical Research
PO Box M77 Missenden Rd
Camperdown NSW 2050
Country 1756 0
Australia
Phone 1756 0
+61 2 95157590
Fax 1756 0
+61 2 95575059
Email 1756 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant underlying published results only.
When will data be available (start and end dates)?
Data will be made available upon request, after publication, with no end date determined.
Available to whom?
Data will be made available upon request, after publication and will be determined upon negotiation with researchers who provided a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Secure data transfer and signed data access agreement. Contact: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Published: 01 August 2010 https://doi.org/10.1093/... [More Details]

Documents added automatically
No additional documents have been identified.