Digital health company ResApp Health (ASX: RAP) has updated the market with positive top-line results from its prospective, blinded at-home obstructive sleep apnoea study that included 308 patients.
Sleep apnoea is a common sleep disorder where the person repeatedly stops breathing or has periods of shallow breathing during sleep. As things stand, nearly 1 billion people suffer from sleep apnoea and 80% of those with moderate or severe sleep apnoea remain undiagnosed.
In order to counteract this significant problem, ResApp has developed a non-intrusive mobile phone application that records people’s breathing and coughing sounds and is then able to accurately diagnose respiratory problems in patients.
The technology works by using sophisticated algorithms which help to identify the wide variety of possible issues.
Just last month, the smartphone app received CE Mark certification as a Class 2a medical device thereby validating and securing its future marketability as a diagnostic test for acute paediatric respiratory disease.
The “software-only solution” can accurately diagnose lower respiratory tract disease, croup, pneumonia, asthma/reactive airway disease and bronchiolitis by using machine learning algorithms that analyse a patient’s cough sounds to make a diagnosis.
Following the receipt of this classification, ResApp said it planned to take its technology to market globally, including Europe as a major springboard for other markets.
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.
The study principal investigators were Dr Philip Currie and Dr Ivan Ling of Cardio Respiratory Sleep (CRS), a company that provides a “full range of respiratory and sleep diagnostic services”.
The study endpoints were ResApp algorithms’ performance in identifying three severities of OSA: more specifically; mild, moderate and severe when compared to an American Academy of Sleep Medicine (AASM) Type 2 sleep study performed simultaneously in the patient’s home.
“This very large study, which recruited over 2,000 patients, conducted both in the sleep laboratory and at home has developed and validated a simple and accurate screening tool using only a smartphone in the bedroom,” said Dr Philip Currie.
“The clinical need is great and growing and it remains unaddressed by today’s methods such as questionnaires and Type 4 sleep testing devices,” he added.
To start with, ResApp’s algorithms analysed a person’s breathing and snoring sounds recorded using a smartphone placed on a bedside table. These sounds were then processed with ResApp’s technology which was able to accurately identify obstructive sleep apnoea (OSA) when compared to a simultaneous at-home comprehensive sleep study.
ResApp’s algorithms correctly identified patients with OSA across the three apnoea hypopnoea index thresholds, with a sensitivity of 85%, 83% and 83%, respectively.
According to ResApp, the study demonstrated that its algorithms, when used at home, have an excellent ability to identify mild, moderate or severe OSA.
“We achieved excellent performance previously during our in-laboratory sleep studies and it is great to see the same high levels of performance replicated in our intended use setting, in peoples’ homes,” said Tony Keating, chief executive officer and managing director of ResApp.
“By delivering a highly scalable, low-cost smartphone app for OSA screening we have a huge opportunity to reduce the health and economic impact of undiagnosed OSA. We will now move forward into the regulatory submission and commercialisation phases of this exciting project,” said Mr Keating.
ResApp shares had risen by over 9% up to $0.24 per share in morning trade.