UK trial will test digital tinnitus therapy from Oto
Just over a year after completing a seed financing round, digital health company Oto has launched a trial of its mobile app that aims to support people with tinnitus, a disabling condition that causes ringing, buzzing, or other noises in the ears.
The start-up is partnering with clinical trial specialist Lindus Health on the decentralised trial, which, according to the partners, will have a "fully remote" protocol allowing subjects to complete the study without having to visit a clinic.
Oto's eponymous app provides a series of cognitive behavioural therapy (CBT), mindfulness, physician exercise, and relaxation techniques designed to help people limit the effects of tinnitus, helping people to live with the symptoms.
It uses a technique called habituation, a phenomenon that allows people to "tune out" unpleasant noises such as traffic or loud engines after they are exposed to the sound for a while, but still focus on conversation or music.
The trial will enrol 198 patients across the UK and assess Oto’s smartphone tinnitus management programme against therapist-delivered CBT in achieving improvement in self-reported tinnitus severity in adults.
OTO's chief executive, Edmund Farrar – a former RAF medic who developed tinnitus whilst in service in his mid-20s – said the trial is a "significant milestone" for the new company and promises to be "groundbreaking tinnitus research."
There is currently no cure for tinnitus, which in the UK is estimated to affect 6 million people, around 15% of the population, according to NHS figures.
Face-to-face CBT has been shown to be effective for tinnitus sufferers, but the typical wait time for this therapy was up to nine months on the NHS, even before the massive increase in waiting lists that followed the pandemic and shows little sign of improving.
Oto is already available for Android and iOS devices and is used in five- to 10-minute sessions, ideally every day. The company – which raised just over $3 million in seed financing last year – is currently offering a seven-day free trial with a monthly subscription thereafter directly to users.
Consultant ENT surgeon Matthew Smith of Cambridge University Hospitals, chief investigator for the trial, said that the digital approach is compelling as there is "little limit on expansion to enable far more patients to be treated, whilst still maintaining much of the personalisation of therapy that tinnitus patients benefit from."
Lindus Health, meanwhile, is fast becoming a key partner for companies seeking to run trials of their digital health products. Earlier this year, it was contracted by German company Dopavision to run a UK study of its therapy for myopia or short-sightedness in children based on virtual reality and a smartphone app.