A randomised controlled trial of multi-night screening and diagnosis of obstructive sleep apnoea -assessing diagnostic test accessibility, accuracy and impact on participant costs.

Patients will be randomly assigned to one of 2 different diagnostic pathways. Pathways 1 and 2 will receive identical multi-night sleep evaluations as well as conventional 1-night polysomnography (PSG) test. The only difference between pathway 1 and 2 is the order in which sleep physicians will receive the clinical data to make diagnostic decisions from, Physicians will provide their initial diagnosis (primary outcome) based on either multi-night screening data or conventional 1-night PSG. Pathway 1 will receive the multi-night data first for the physician to determine the presence of sleep apnoea and then will receive the single night PSG data; Pathway 2 will receive the single night PSG data first, followed by the multi-night data and physicians will be asked to make decisions about the presence of sleep apnoea and diagnostic accuracy. Multi-night measurements will include an under-mattress sleep sensor device, such as the Withings Sleep Analyzer (Withings) to be used for up to 14 nights, a forehead-worn electrode sensor device such as Somfit (Compumedics) to be used for up to 7 nights, and a simple ring-like oximeter device worn on a finger, such as the Wellvue pulse oximeter to be used for up to 7 nights. The forehead-worn electrode sensor device and the simple ring-like oximeter will be used simultaneously ie both worn together and the under-mattresss sensor will also be used on the same nights with these 2 devices. Device analytics will allow measurement of sleep duration, severity of OSA and whether the device was applied successfully. In addition to the multi-night assessments, participants will undergo a full PSG sleep study at a separate timepoint . These two pathways will differ only in the order with which physicians receive multi-night data, either before or after single night PSG data and this will occur prior to review with the participant and commencement of any treatment. Physicians will undergo an education session prior to the first participant being recruited on how to interpret the data from the devices. Participants (patients) will receive training in how to use the devices (as per manufacturers instructions) by clinical staff at the sleep laboratory or by research assistants/coordinators at each site with telephone support for participants. The overall duration of sleep assessment using the multi-night devices will be 14 days after randomisation. Participants(patients) will undergo follow-up to capture and compare short- (3 months) and longer-term (12 and 24 months) clinical outcomes for OSA in terms of symptoms, quality of life, therapy used for OSA which will be measured by questionnaires. Medicare and Pharmaceutical benefits data for each participant will also be obtained.