Sheffield sleep gadget produced by insomniac wins approval in US
A Sheffield ‘sleep tech’ company has won access to 70m American insomniacs after its gadget was approved by the FDA.
SleepCogni is celebrating after its hand-held device was registered for medical use by the Food and Drug Administration.
It follows a clinical trial at Sheffield Hallam University which showed it reduced insomnia in seven days, bosses say.
Richard Mills, co-founder and CEO of SleepCogni, said: “FDA registration is a major development for the company, giving us access into the American market where, according to the Centres for Disease Control and Prevention, one in three people suffer with insomnia at some point in their lives.
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“This coincides with an agreement to roll out the device in 130 US sleep clinics following the successful completion of final testing.”
Mr Mills co-founded SleepCogni alongside Dutch chronobiologist and sleep expert, Dr Maan van de Werken, after suffering from insomnia for several years.
Since it was founded in 2015, the company has raised almost £1.8m to support development.
Leading the clinical trials were Dr Antonia Ypsilanti, associate professor of cognitive psychology and Dr Lambros Lazuras, associate professor in social psychology at Sheffield Hallam University.
Dr Ypsilanti said: “The SleepCogni trials produced extraordinary results, reducing clinical insomnia to subthreshold insomnia in just seven days for those using the device.”
The hand-held aid enables users to self-manage their insomnia by collecting data to provide informed insights for clinical intervention.
It has secured 11 patents including ones for its wind down technology, Active-Biofeedback, which uses haptic feedback to help insomnia suffers break cognitive cycles preventing sleep.