Brisbane, Australia, 1 July 2019 — ResApp Health Limited (ASX:RAP), a leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease, today announced that it has recruited 200 patients in its double-blind, prospective at-home obstructive sleep apnoea (OSA) study. The company is targeting a minimum of 250 patients and expects to complete recruitment and release top-line results during the third quarter of this calendar year.
Patients are recruited into the study if they are referred for home-based sleep testing and then undergo simultaneous smartphone-based audio recording and polysomnography in their own home.
ResApp previously announced positive results from a prospective OSA clinical study which recruited 582 patients undergoing simultaneous in sleep laboratory polysomnography. This study confirmed that ResApp’s algorithms were able to accurately identify OSA from a patient’s overnight breathing and snoring sounds recorded using a smartphone placed on a bedside table. For identifying mild, moderate or severe sleep apnoea (apnoea hypopnea index greater than or equal to 5/h), ResApp’s algorithms achieved a sensitivity of 84% and specificity of 83%.
“Demonstrating the accuracy of our OSA detection algorithms in the home setting will be an important milestone in the development of a highly-scalable, accurate and easy-to-use screening test for OSA,” said Tony Keating, CEO and Managing Director of ResApp. “Screening of OSA today relies mostly on questionnaire-based screening tools, which in a study recently published in the Medical Journal of Australia were found to have a sensitivity as low as 36-51%, meaning that a large portion of people with clinically relevant OSA are missed. This highlights the need for a more accurate screening tool. The recent inclusion of these screening questionnaires into the requirements for Medicare reimbursement of sleep testing has impacted recruitment, however we are now close to finalising recruitment and are looking forward to releasing results from the study during the third quarter.”
About Sleep Apnoea
Sleep apnoea is a common sleep disorder where the person repeatedly stops breathing or has periods of shallow breathing during sleep. Recent data from the Wisconsin Sleep Cohort Study showed that sleep apnoea affects more than three in ten men and nearly two in ten women. 80 percent of people suffering moderate and severe sleep apnoea are undiagnosed. Untreated OSA is known to increase the risk of heart disease, hypertension, stroke and type 2 diabetes, and is estimated by the American Academy of Sleep Medicine to cost the US economy $149.6 billion annually.
About ResApp Health Limited
ResApp Health Limited (ASX: RAP) is a leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease. ResApp’s machine learning algorithms use sound to diagnose and measure the severity of respiratory conditions without the need for additional hardware. Clinical studies at leading hospitals in the United States and Australia have demonstrated accurate diagnosis of pneumonia, asthma/reactive airway disease, bronchiolitis, croup, chronic obstructive pulmonary disease and upper respiratory tract infections. ResApp has also obtained excellent results for screening of obstructive sleep apnoea in a double-blind, prospective clinical study. Potential customers of ResApp’s products include healthcare providers in telehealth, emergency department, urgent care and primary care settings as well as humanitarian organisations in the developing world. For more information, please visit www.resapphealth.com.au
ResApp Health Limited
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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.