Successful clinical trials for insomnia device developed in Yorkshire
The team behind Sheffield-based sleep therapy solution SleepCogni is celebrating after their device produced “extraordinary” clinical trial results, significantly reducing clinical insomnia after seven days.
Following the trials, conducted at Sheffield Hallam University with a group of 80 people suffering from chronic insomnia, the device is now primed to be launched on to the global $80bn sleep aid market.
SleepCogni is a hand-held sleeping aid which helps insomnia sufferers break cognitive cycles that prevent sleep.
Co-founded by Sheffield-based entrepreneur Richard Mills, who has personally suffered from sleeping disorders, and Dutch chronobiologist and sleep expert, Dr Maan van de Werken, the device enables users to self-manage their insomnia, a condition which affects one in three people across the world.
During its clinical trial the device was found to significantly reduce participants’ clinical level of insomnia to non-clinical levels in just seven days, with a substantially faster reduction achieved on the Insomnia Severity Index than typically seen with other forms of treatment.
The trials follow the device’s registration with the Food and Drug Administration (FDA), announced earlier this month, opening up immediate access to an estimated 70m sleep sufferers living in the US.
SleepCogni is now about to embark on a new investment round to help build its brand in the US and across other global markets.
The company’s team of advisers comprises respected figures from the global healthcare sector, including SleepCogni’s chairman Richard di Benedetto, president of Aetna International health insurance.
Van de Werken, company co-founder and chief scientific officer, said: “We’re hugely encouraged by the results from our largest trial to date, with 80 participants suffering from chronic insomnia taking part.
“The user feedback was outstanding and the reduction of insomnia complaints recorded in the patients that used our device was substantial.”
Mills, co-founder and CEO, added: “The success of the clinical trials marks another important step forward in SleepCogni’s progress.
“These outstanding results, combined with FDA registration give us positive momentum as we seek to develop our brand across global markets, including the US.”
The clinical trials were led by Dr Antonia Ypsilanti, associate professor of cognitive psychology and Dr Lambros Lazuras, associate professor in social psychology at Sheffield Hallam University.
Ypsilanti said: “The SleepCogni trials produced extraordinary results, reducing clinical insomnia to subthreshold insomnia in just seven days for those using the device.
“It’s ground-breaking to see such a drastic improvement on insomnia severity, and unsurprising to hear participants commenting how the device helped them relax and gain control of their sleep with many claiming it was better than any other sleep improvement approaches they’d used in the past.”
