The diagnosis of Obstructive Sleep Apnea (OSA) in primary care

Development and validation of a diagnostic algorithm for the diagnosis of Obstructive Sleep Apnea (OSA) in primary care

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12608000417381

Enrollment

570

Registered

2008-08-25

Start date

2008-09-16

Completion date

2011-01-06

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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.

Outcome results