None listed
Conditions
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.
Interventions
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
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.
Sponsors
The Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed