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Originally featured on Stockhead. 

• TrivarX is pioneering AI technology to screen for mental health disorders via sleep monitoring
  
  
• While connection between mental health and sleep is well-known it is an overlooked area of sleep studies and in sleep clinics globally
  
  
• TrivarX’s technology is focused on rapid eye movement, heart rate variability and N3 sleep to determine patterns linked to depression

Special Report: TrivarX is using artificial intelligence to gain sleep data, which could help with the diagnosis and better treat mental health disorders.

TrivarX (ASX:TRI) has an AI-driven screening and diagnostic tool – the MEB-001 device – to assist in the screening and long-term monitoring of mental illness and mood disorders.

Chief operating officer Kai Sun told Stockhead the connection between sleep disturbances and mental health is well known. However, he says mental health is still an overlooked area of sleep studies and there is no screening for mental health disorders in sleep clinics in the US or globally.

“People have always analysed sleep and mental health but no one has been able to connect the link in order to provide an objective assessment,” he says.

Sun says HRV is a sensitive indicator of sleep deprivation. Those who take longer to fall asleep typically have higher heart rates and lower HRV.

Chronic insomnia and sleep deprivation can also reduce HRV, and individuals with depression often show lower HRV levels.

The company’s MEB-001 device screens sleep study patients for mental health disorders. It uses biometric data, EEG (brain), ECG (heart Rate) and HRV recordings collected during in-clinic sleep studies.

“The critical element in our technology and what is proprietary to us, is that we’ve been able to identify biomarkers associated with sleep and heart rate variability that no one else has been able to do,” he says.

Depression linked with disrupted sleep

Sun says 75% of people with diagnosed depression suffer from disruptive sleep patterns and more than one in five people undergoing a sleep study have confirmed depression.

“However, there is no mental health screening conducted in sleep clinics in the US or globally, and less than 1.5% of people are actually screened for depression at the primary care level,” he says.

“It’s known that sleep and mental health are intricately linked and we can dive deeper into that – 80% of people who have depression and are on CPAP therapy for a sleep condition don’t do it.

“The fact that they’re being prescribed CPAP therapy but not being screened for their medical state in identifying and treating the depression ultimately leads to worse medical outcomes for these patients.”

Continuous positive airway pressure (CPAP) is a machine that helps open up the airways while you sleep and is prescribed for conditions like sleep apnoea.

Focus on REM and N3 sleep

Sun says the key areas within sleep which TrivarX’s AI-backed algorithms are focusing on for mental health are rapid eye movement (REM) sleep and N3 (slow-wave or delta) sleep.

He says people with depression typically have shortened N3 sleep cycles and their REM sleep cycles get longer.

TrivarX’s technology looks at more than 60 biomarkers during REM and N3 sleep stages as well as heart rate variability (HRV) to learn variables that turn into predictors of what typically happens with depression sufferers.

“People with depression will normally dream heavier at the start of the night because their N3 sleep stage in the first part of the night is shorter than people without depression,” he says.

“What we really try to identify is the appearance of REM and N3 during a cycle at night and for what duration.”

Complexity of treating sleep and depression

Sun says sometimes medications to treat mental health conditions such as depression can have a negative impact on sleep cycles so treatment can be complex.

“Medication can change REM cycles so if a clinician doesn’t choose the right medication, quite often they might suppress the depressive symptoms but affect their sleep for worse,” he says.

Sun says if a person is not getting the required amount of REM or N3, or right cycles of both, it may adversely affect their mental health.

“We have looked at millions of data points, run several clinical trials and have one of the largest repositories of sleep study data that has been labelled with a patient’s mental health status,” he says.

“We can really analyse all those different moments within sleep among people with confirmed depression to understand what has been happening with not only their sleep cycles, but heart rate variability as the heart, brain and whole system is intricately linked during sleep.”

Experienced team at forefront of technology

Sun says TrivarX’s tech came from its chief medical officer, Dr Archie Defillo and head of AI, Dr Massimiliano Grassi.

Defillo was a practising neurosurgeon in South Africa for more than 25 years and has spent the last part of his career in research around the brain.

“That is where his knowledge about the clinical side and how the brain works formed the basis of what to look and test for,” Sun says.

“Grassi has been working in artificial intelligence for nearly 20 years and has a PhD in psychology, so he is a unique mix of someone smart and knowledgeable with coding but also understands the psychology of mental health.”

Sun also oversees the investment portfolio for Seefeld Investments, a family office based out of Perth and the third largest shareholder in TRI.

“At the moment, our portfolio consists of 18-20 companies with a specific interest in wellness and education so TrivarX falls into our investment philosophy,” he says.

“Since our involvement at a board and investment level I stepped into an operational role.”

Sun notes the company also has Chris Ntoumenopoulos and Dr Tony Keating on the board, who were both founding directors of ResApp Health.

The former ASX-listed company known for its diagnostic respiratory app was acquired by Pfizer in 2022 for around $200m.

“The technology we have at TrivarX really attracted both of them to get involved,” Sun says.

“Tony, in particular, having been more on the ground with ResApp, had been consulting with the company but on the back of our strong Phase 2 trial results, he stepped in as executive director to lead through this next phase of growth.

“His expertise in running a pivotal trial, liaising with FDA and progressing a formal submission and then ultimately commercialising technology within the digital health space puts us in a strong position to kick some goals in the next 12 to 18 months.”

“Our team is a bunch of really smart people who know how the brain works and how to use AI to pick up what the human eye can’t see.

“Right now, researchers are going through the literature and often analysing sleep manually but it’s just not possible to identify what we have without the use of AI.”

Positive data from Phase 2 trial

TRI recently announced positive results from its Phase 2 Sleep Signal Analysis for current Major Depressive Episode (SAMDE) study using MEB-001.

The positive results from its SAMDE study leaves TrivarX well positioned to start a pivotal trial for FDA approval, which it’s hoping to get underway before the end of CY24.

“Based on our conversations with the FDA to date we believe the pivotal trial will be almost a carbon copy of the Phase 2 trial with the same number of patients and conducted the same way,” Sun says.

“We have a meeting with the FDA coming up and once that has been had, they’ll give us the tick to commence the pivotal trial.

“We expect the trial duration to be anywhere from three to six months and once completed, we can prepare materials for FDA submission.”

Beyond depression and even into consumer wearables

Sun says depression is the immediate opportunity for TrivarX but the team is excited to expand into other mental health indications such as anxiety, bipolar and PTSD.

“We can also make it more accessible through consumer wearables so beyond a clinical sleep study,” he says.

“Right now, the team is working on creating algorithms that don’t require all the inputs from an in-clinic sleep study but only require, for example, your brain signals so we could deploy the technology into headsets that track brain signals.

“Similarly, we could take the technology to home sleep studies, which are less intrusive and there are more being conducted.”

He says further along, TrivarX may even be able to provide software for consumer wearable health devices to monitor mental health conditions or sleep.

“The blue-sky opportunity for the company is to take our technology into mass consumer wearables like Apples watches and Garmins,” he says.

“We believe we will be able to provide deeper insights on sleep and the objective assessment of mental health based on the physiological data of its wearers.”