The basis of this study is evidence of the positive treatment effect (improved state of health) and the assessment decision of the BfArM (German Federal Institute for Drugs and Medical Devices) for permanent approval as a digital health app. The BfArM’s opinion:“The results of the statistical analyses provide information that the use of the self-help program somnio can successfully reduce symptoms of insomnia in the long term.”
The randomised controlled study by the University of Zurich provided evidence that in users of the digital sleep training, insomnia symptoms were reduced on average by 50%. Furthermore, the waking time in the night in the intervention group was shortened on average by 31 minutes and users were able to fall asleep 18 minutes faster on average. A follow-up also showed that the improvement effects were still stable 12 months after application.