Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000417381
Ethics application status
Approved
Date submitted
27/06/2008
Date registered
25/08/2008
Date last updated
14/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The diagnosis of Obstructive Sleep Apnea (OSA) in primary care
Scientific title
Development and validation of a diagnostic algorithm for the diagnosis of Obstructive Sleep Apnea (OSA) in primary care
Secondary ID [1] 676 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea (OSA) 3329 0
Condition category
Condition code
Respiratory 3484 3484 0 0
Sleep apnoea

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Subjects presenting to the primary care practitioner (PCP) in metropolitan and regional areas with suspected OSA will undergo a clinical evaluation, answer questionnaires, and have a photograph taken of their face and profile. After this visit they also be tested for 3 nights at home on a portable nasal flow monitor (Flow Wizard, DiagnoseIt, Sydney, Australia) and undergo a single night in-hospital polysomnogram (the reference standard test used to diagnose obstructive sleep apnea).

Information collected during the 15-20 minute primary care practitioner visit are:
demographic and anthropometric characteristics (weight, height, neck circumference, waist circumference, hip circumference),
questionnaires of sleep apnea symptoms and sleepiness (Epworth Sleepiness Scale; Multivariate Apnea Prediction Index; Berlin Questionnaire), and digital photography of face and neck (technique analgous to cephalometric x-rays to characterise anatomical variations that may be associated with OSA).

All testing will be performed within a 6-week period.
Intervention code [1] 3063 0
Not applicable
Comparator / control treatment
Not-applicable - Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4389 0
Diagnostic accuracy of a diagnostic algorithm combining the variables and measurements, to rule in and rule out the presence of OSA.
Timepoint [1] 4389 0
At end of algorithm development when an optimal set of variables to diagnose obstructive sleep apnea will be determined (at approximately 15 months) and end of the validation phases of study (when the algorithm will be tested with a new set of patients, at approximately 27 months).
Secondary outcome [1] 7408 0
Satisfaction and ease-of-use of the diagnostic algorithm, rated by GPs and involved practice staff, rated by Likert-type scales.
Timepoint [1] 7408 0
End of development (at approximately 15 months) and end of validation phases of study (at approximately 27 months.)
Secondary outcome [2] 7409 0
Patient preference for diagnostic algorithm compared with standard in-laboratory polysomnography.
Patients will rate aspects of the diagnostic algorithm and the standard in-laboratory polysomnography on standard Likert scales.
Timepoint [2] 7409 0
Upon each patient's completion of the study.

Eligibility
Key inclusion criteria
age 18-75, presents to GP with suspicion of OSA based on symptoms of sleep apnea (snoring, choking, witnessed apneas or daytime sleepiness) and/or conditions associated with OSA (such as obesity or the metabolic syndrome).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2008
Actual
16/09/2008
Date of last participant enrolment
Anticipated
Actual
6/01/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
570
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1053 0
2050
Recruitment postcode(s) [2] 1054 0
2065
Recruitment postcode(s) [3] 1055 0
2037
Recruitment postcode(s) [4] 1056 0
2170
Recruitment postcode(s) [5] 1057 0
2217

Funding & Sponsors
Funding source category [1] 3531 0
Government body
Name [1] 3531 0
National Health and Medical Research Council
Country [1] 3531 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
PO Box M77, Missenden Road NSW 2050
Country
Australia
Secondary sponsor category [1] 3169 0
None
Name [1] 3169 0
Address [1] 3169 0
Country [1] 3169 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5568 0
Sydney South West Area Health Service (SSWAHS) Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 5568 0
Research Development Office, Level 8, Building 14, Royal Prince Alfred Hospital, Camperdown, NSW 2050
Ethics committee country [1] 5568 0
Australia
Date submitted for ethics approval [1] 5568 0
Approval date [1] 5568 0
02/06/2008
Ethics approval number [1] 5568 0
X08-0125

Summary
Brief summary
Obstructive sleep apnea (OSA) is a common and treatable condition with significant consequences in terms of morbidity as well as mortality. Currently diagnosed with an in-laboratory polysomnogram (PSG) in the context of specialist consultation, this pathway is both labour- and resource-intensive. The burden of undiagnosed and untreated disease imposes a great economic cost to the community in terms of injuries, lost productivity and associated medical conditions. We propose to test the utility of a nasal-flow based diagnostic device, anatomical features from analysis of photographic images of the head and neck, as well as clinical information from questionnaires and biometrics, in General Practice. Subjects presenting to the primary care practitioner (PCP) in metropolitan and regional areas with suspected OSA will undergo a clinical evaluation, answer questionnaires, have a photograph taken of their face and profile and be tested for 3 nights at home on a portable nasal flow monitor. The reference standard will be an in-laboratory polysomnogram. A diagnostic algorithm will be developed and validated, combining the factors giving the best prediction of OSA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28709 0
Prof Ronald Grunstein
Address 28709 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road NSW 2050
Country 28709 0
Australia
Phone 28709 0
+61 2 9114 0000
Fax 28709 0
Email 28709 0
[email protected]
Contact person for public queries
Name 11866 0
Dr Keith Wong
Address 11866 0
PO Box M77, Missenden Road NSW 2050, Australia
Country 11866 0
Australia
Phone 11866 0
+61 2 9114 0445
Fax 11866 0
+61 2 9114 0014
Email 11866 0
[email protected]
Contact person for scientific queries
Name 2794 0
Dr Keith Wong
Address 2794 0
PO Box M77, Missenden Road NSW 2050, Australia
Country 2794 0
Australia
Phone 2794 0
+61 2 9114 0445
Fax 2794 0
+61 2 9114 0014
Email 2794 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

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