Clinical efficacy of somnio

The RCT at the University of Zurich randomised patients with a diagnosis of “insomnia” into a treatment group (use of somnio) and a waiting list control group. In the treatment group, insomnia symptoms reduced by 50% over the treatment period, while there was no significant change in the control group. Furthermore, sleep onset was faster and waking in the night was significantly reduced in the treatment group. The treatment effect was also stable after 12 months (follow-up survey). After treatment with somnio, 56% of participants in the treatment group were in remission, i.e. they no longer met the diagnostic criteria for insomnia. In the control group, only 11% were in remission.

Evaluation decision of the BfArM

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.”

What is a positive treatment effect?

A DiGA (digital health app) offers a positive treatment effect if the patient’s health improves or the chance of dealing with the disease is improved by the use of the health application.
This can either be a direct influence on, for instance, the symptoms of a disease or complaints associated with the disease, such as reducing pain.
This is what is considered a medical benefit. This also includes improved quality of life associated with the health situation.

What are the study conclusions?

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.

an application by

mementor DE GmbH

Karl-Heine-Straße 15
04229 Leipzig
Germany