The diagnosis of Obstructive Sleep Apnea (OSA) in primary care
Not Applicable
Completed
- Conditions
- Obstructive Sleep Apnea (OSA)Respiratory - Sleep apnoea
- Registration Number
- ACTRN12608000417381
- Lead Sponsor
- Woolcock Institute of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 570
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).
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of a diagnostic algorithm combining the variables and measurements, to rule in and rule out the presence of OSA.[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 Measures
Name Time Method Satisfaction and ease-of-use of the diagnostic algorithm, rated by GPs and involved practice staff, rated by Likert-type scales.[End of development (at approximately 15 months) and end of validation phases of study (at approximately 27 months.)];Patient preference for diagnostic algorithm compared with standard in-laboratory polysomnography.<br>Patients will rate aspects of the diagnostic algorithm and the standard in-laboratory polysomnography on standard Likert scales.[Upon each patient's completion of the study.]