ResApp Health (ASX: RAP) has achieved “excellent” preliminary results in its obstructive sleep apnoea trial using its smartphone application.
The company is carrying out clinical proof-of-concept studies using its new machine learning algorithms to measure the severity of obstructive sleep apnoea on sufferers via a smartphone.
A patient places their smartphone on a bedside table and while they sleep, the phone records and measures breathing and snoring sounds. The application’s algorithms analyse the sounds for presence and severity of sleep apnoea.
ResApp is working with Dr Philip Currie and Dr Ivan Ling and study participants have been recruited through Western Australia’s Hollywood and The Park private hospitals.
Preliminary results from the study have achieved 86% sensitivity and 83% specificity using ResApp’s platform in identifying patients with an apnoea hypopnea index of 15 or above, which is moderate to severe sleep apnoea. Traditional in-laboratory polysomnography was carried out at the same time and the results were compared.
ResApp’s platform and the in-laboratory polysomnography both had similar results in identifying patients with apnoea hypopnea index of 30 or more, which is classified as severe sleep apnoea.
“We are very excited about these excellent preliminary results for identifying obstructive sleep apnoea,” ResApp managing director and chief executive officer Tony Keating said.
“There is a strong clinical and economic need for reducing the number of undiagnosed sleep apnoea sufferers and by utilising a smartphone, we have the opportunity to deliver a highly-scalable, accurate and easy to use screening test to the mass market,” he said.
ResApp has been developing smartphone applications for diagnosing and managing respiratory diseases including asthma.
“By leveraging our expertise in using audio signatures to identify respiratory conditions, we have created another large commercial opportunity,” Mr Keating added.
A large cohort of 731 patients was used to obtain the results with a mean age of 53. Of those patients, 62% were male and 38% female.
A sleep cohort study in Wisconsin revealed more than three in every 10 men were affected by sleep apnoea, while nearly two in every 10 women were impacted.
However, 80% of sufferers are undiagnosed. According to ResApp, untreated sleep apnoea in sufferers can increase the risk of heart disease, hypertension, stroke and type 2 diabetes.
It is estimated sleep apnoea and its associated health risks cost the US economy almost A$150 billion a year.
Sleep laboratory polysomnography or specialised home equipment are currently used to diagnose the condition.
ResApp claims neither method is amenable to mass screening for the condition due to the high cost and low availability of the monitoring and diagnostic equipment. Additionally, patients can find the testing to be complicated and uncomfortable.
Today’s news follows ResApp’s update on its SMARTCOUGH-C-2 study which is investigating the efficacy of its ResAppDx smartphone application in diagnosing acute childhood respiratory diseases using coughing sounds.
The SMARTCOUGH-C-2 study will enrol up to 1,667 patients from 29 days old through to 12 years who have presented at one of three US clinics with symptoms of an acute respiratory diseases.
In the study, ResApp’s technology diagnosis will be compared with a clinical diagnosis.
In yesterday’s update, Mr Keating said recruitment rates had exceeded last year’s rates due to a worse-than-normal flu season in the US.
“We also note that the improvements we made in training and processes are yielding high quality audio data and that our efforts to homogenise clinical adjudication practices have been well received by the participating hospitals and independent clinical adjudication team,” he said.
Study results are anticipated mid-year with the company looking to fast-track the regulatory and commercialisation process of its ResAppDx.
If commercialised, ResApp hopes its technology can replace stethoscope, x-ray and CT scans, spirometry, as well as blood and sputum tests in offering a rapid respiratory disease diagnosis.
Shares in ResApp fell more than 14% in trade today to end the day at A$0.15.