Brisbane, Australia, 12 July 2018 — ResApp Health Limited (ASX:RAP), a leading digital health company developing smartphone applications for the diagnosis and management of respiratory disease, is pleased to provide an update on its clinical study in obstructive sleep apnoea (OSA). Recruitment in the double-blind prospective study is progressing well, with 312 patients recruited as of 11 July. The company is targeting a minimum of 500 patients and expects to reach this target in the third quarter of this calendar year.
ResApp previously announced that it had developed a sound-based algorithm that identified moderate and severe OSA using a smartphone placed on a bedside table with a proof-of-concept study of 731 patients showing 86% sensitivity and 83% specificity when compared to simultaneous in-laboratory polysomnography. ResApp is looking to confirm these findings in its double-blind prospective study.
The prospective study has also been expanded to include patients undergoing at-home sleep testing.
“We are happy to be well past the halfway point for recruitment in our sleep apnoea study and firmly on track to apply for regulatory approval before the end of this calendar year,” said Tony Keating, CEO and Managing Director of ResApp. “Sleep apnoea is widespread, affecting a third of the male adult population, yet 80% of people who suffer from moderate or severe sleep apnoea remain undiagnosed. A highly-scalable, easy to use, at-home screening tool would have significant clinical usefulness and a major impact on population health, especially as undiagnosed sleep apnoea has been linked to serious complications such as heart disease and type 2 diabetes.”
ResApp’s sleep apnoea program is one of three major clinical programs being undertaken by the company. Recruitment in ResApp’s two pivotal clinical studies targeting the acute diagnosis of respiratory disease using cough sounds recorded on a smartphone, SMARTCOUGH-C-2 (recruiting in the United States) and Breathe Easy (recruiting in Australia), is on track in both cases and should be completed by the end of this month. Results will be reported soon afterwards, following the finalisation of clinical adjudication and data verification.
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 underway 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 proof-of-concept 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 on ResApp, visit www.resapphealth.com.au