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Brisbane, Australia, 29 June 2020 — ResApp Health Limited (ASX:RAP), a leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease, today announced the launch of SleepCheck, a clinically validated at-home sleep apnoea screening app. SleepCheck is a mobile medical device software application that analyses a user’s breathing and snoring sounds during sleep and provides an assessment of their risk of sleep apnoea.

In a large clinical study, SleepCheck’s algorithms were shown to accurately assess a person’s risk of sleep apnoea when compared to a full sleep test. SleepCheck requires no accessories or hardware other than the user’s smartphone and is CE Marked in Europe and Therapeutics Goods Administration (TGA) approved in Australia.

Sleep apnoea is a serious medical condition that is often associated with loud snoring and affects more than three in every ten men and nearly two in every ten women. Sleep apnoea is when air stops flowing to your lungs for ten seconds or longer during sleep creating an ‘apnoea’ event. In severe cases, this can happen more than 30 times per hour. Studies have shown that 80% of people with sleep apnoea are undiagnosed. Untreated, sleep apnoea causes daytime tiredness, reduced productivity at work and an impaired immune system, and has been linked to serious complications such as heart disease, hypertension, stroke and type 2 diabetes.

“We are excited to announce that SleepCheck is now available on the App Store. For the first-time, consumers have direct access to a clinical-grade, regulatory-approved screening tool for sleep apnoea,” said Tony Keating, CEO and Managing Director. “Over a third of Australian adults do not get the duration or quality of sleep needed, which has major consequences for their health, safety and quality of life. Many adults snore, and loud snoring is an important indicator of sleep apnoea, although it often is ignored. SleepCheck offers an easy way to check if there’s more to your snore.”

How SleepCheck works
After downloading the app, the user places their smartphone on a bedside table and starts the SleepCheck app prior to going to sleep. Using the smartphone’s built-in microphone, SleepCheck records the user’s breathing and snoring sounds while they sleep. SleepCheck’s clinically validated algorithms analyse these sounds to provide an accurate assessment of the user’s risk of sleep apnoea (low, medium, high or very high). Based on this personalised assessment, the user is provided with recommended next steps to take.

Availability and pricing
The SleepCheck app for iPhone is available to download on the App Store, with Android to follow later this year. It is now available in Australia and the United Kingdom, with other countries to follow based on regulatory approvals and language translations. SleepCheck is available at introductory pricing of $7.99 (£4.99 in the UK).

How accurate are the SleepCheck results?
In a 308 patient clinical study, SleepCheck’s algorithms were shown to accurately identify obstructive sleep apnoea when compared to a simultaneous at-home comprehensive sleep study (ASX announcement 30 September 2019). The algorithms determine the apnoea hypopnoea index (AHI) during sleep. AHI is a measure of the number of pauses in breathing that a person experiences per hour of sleep. An AHI of 5/h is considered to be mild sleep apnoea, while an AHI greater than 30/h is considered severe. A summary of clinical performance is presented below:

Sensitivity Specificity
AHI ≥ 5/h (Mild) 85% 73%
AHI ≥ 15/h (Moderate) 83% 80%
AHI ≥ 30/h (Severe) 83% 90%

SleepCheck does not provide a diagnosis and is not intended as a substitute for a full sleep study using polysomnography.

SleepCheck uses clinically accurate algorithms to assess a user’s risk of obstructive sleep apnoea by analysing their breathing and snoring sounds during sleep.

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About ResApp Health Limited
ResApp Health Limited (ASX: RAP) is a leading digital health company developing smartphone applications for the diagnosis and management of the respiratory disease. ResApp’s machine learning algorithms use sound to diagnose and measure the severity of respiratory conditions without the need for additional accessories or hardware. ResApp’s regulatory-approved and clinically validated products include ResAppDx-EU, a smartphone-based acute respiratory disease diagnostic test for use in telehealth, emergency department and primary care settings; and SleepCheck, an at-home sleep apnoea screening app for consumers to self-assess their risk of sleep apnoea. Both products are CE Marked in Europe and TGA approved in Australia. For more information, please visit www.resapphealth.com.au.

Contacts for ResApp Health
Dr Tony Keating
CEO and Managing Director
+61 430 180 659
tony@resapphealth.com.au

Brian Leedman
VP, Corporate Affairs
+61 412 281 780
brian@resapphealth.com.au

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ResApp Health Limited
ABN 51 094 468 318
Level 12, 100 Creek St, Brisbane, QLD 4000

© 2020 ResApp Health Limited. All rights reserved. US Patent No. 10,098,569, Australian Patent No. 2013239327, Japanese Patent No. 6,435,257 and Patents Pending. ResApp Health®, the ResApp Health logo and ResAppDx® are registered trademarks of ResApp Health Limited in the United States and other countries. ResAppDx is not available for sale in the United States.