When Professor Colin Espie joined Oxford University in 2013, his extensive portfolio of research already included Sleepio, a digital treatment for insomnia, and the company he had established to commercialise it, Big Health. The region’s health research partnerships then provided the perfect environment for taking Sleepio through from innovation to the clinic.
Sleepio delivers the NICE-recommended first-line treatment for insomnia – cognitive behavioural therapy (CBT) – via a regulated smartphone app and online version. Professor Espie saw that delivering insomnia treatment digitally could increase access to CBT for insomnia, normally limited by the number of clinicians able to deliver it in person. Sleepio has now been validated in 18 randomised controlled trials, providing evidence of its safety and efficacy in multiple populations.
“Treatments need to prove they can help all of us sleep better, not just the easy-to-treat cases,” says Professor Espie. “The randomised controlled trials broadened the research base for Sleepio to cover different populations, such as people with mild cognitive impairment, who’ve had a stroke, and people with other mental health problems. And in all of them, the technology works.”
As the clinical evidence was building, Professor Espie and Big Health also needed to ensure that the app could be put into practice in a real-world clinical setting. Would a digital treatment for insomnia provide benefits for patients, clinicians and the NHS as a whole and be economically viable?
Will Goddard, UK Managing Director at Big Health explains: “Unlike a pharmacological treatment – like a sleeping pill, for example – a digital treatment does not require a prescription. This means a range of healthcare professionals can offer a treatment like Sleepio, from GPs, to practice nurses, to mental health workers – or it can be offered via non-traditional channels, such as someone’s workplace, public health websites, or charities. One of the questions we needed to answer was how this broader access model would work and whether it would reach the people it needed to.”
Proving digital CBT works
In 2018, Big Health partnered with the Oxford Academic Health Network (Oxford AHSN, now Health Innovation Oxford and Thames Valley) to trial a roll-out of Sleepio across the Thames Valley region, funded through Innovate UK.
The results showed high engagement from patients, good recovery levels and positive feedback from clinicians. An independent health economics assessment found the technology had reduced GP appointments and prescription costs, resulting in an overall saving for the NHS.
“The HIN played a critical role,” recalls Will Goddard. “Without their networks and established connections within the region, the project would not have been such a success.”
Thanks to the clinical and real-world evidence, in 2022 Sleepio became the first – and remains the only – digital treatment for insomnia recommended by NICE. It is also cleared by the Food and Drug Administration (FDA) in the USA. It was commissioned in Scotland in 2021 by the Scottish Government to provide first-line treatment for insomnia nationwide, and it remains available to patients and clinicians across the Thames Valley.
In the rest of England, it is only available in a few isolated areas. But this looks set to change. NHS England is developing a national approach to making digital CBT for insomnia available nationwide in England, with NICE also due to update their guidance on the treatment category.
“There are lots of apps that make medical claims but the majority are not backed up by evidence,” says Professor Espie. “If an app is going to be taxpayer-funded, on the NHS, its evidence base needs to be as strong as it would be for a medicine. Providing that evidence base is where collaborations between companies and the health research ecosystem in Oxford pays dividends.”
Goddard agrees. “We’re still working closely with the HIN on assessing different approaches to the implementation and adoption of Sleepio: for example, how best to explain a digital treatment to clinicians and in turn their patients, and how to embed it into clinical workflows, including prescribing software and electronic health records. The HIN has also opened up opportunities to collaborate with other HINs across the country to develop our other digital treatments, which has been valuable.”
The future of sleep research and care
Although this year sees Professor Espie retire from Oxford University, sleep research is now firmly embedded in the region, with Professor Simon Kyle carrying on the theme within the NIHR Biomedical Research Centre: Oxford Health. The future of sleep research will rely on collaboration, according to Professor Espie. “Sleep is relevant in public health, in hospital care and community care, and at all stages of our lives,” he says. “When anyone is assessed for a health need, it makes sense to ask: how are you sleeping? Sleep research should not be isolated, but cross-cutting with other areas, such as children and young people, dementia and chronic pain. That integration is exactly what the BRC and the environment in Oxford is able to provide.”
In the meantime, both Professor Espie and Big Health are waiting to see if Sleepio will be made available more widely across England. A decision is expected in early 2027 – watch this space.
For more information about Sleepio research at Oxford, visit the HIN website: Sleepio – digital sleep improvement programme