A study has confirmed the efficacy of digital sleep training with the somnio app, compared to digital self-monitoring with a sleep diary.

A new randomized controlled trial has, for the first time, confirmed the efficacy of digital sleep training with the somnio app, compared to digital self-monitoring with a sleep diary. The study design was unique in Germany, because it used an active control group and allowed clear conclusions to be drawn about the specific effects of Cognitive Behavioral Therapy for Insomnia (CBT-I) with somnio. The study also used objective sleep measurements via actigraphy, compared to self-monitoring alone.
The results show that digital sleep training with somnio significantly reduces insomnia symptoms and improves relevant sleep parameters. The use of somnio also led to an increase in the general well-being and quality of life of the users. The study was published in the Journal of Sleep Research (JSR) in June 2024. Overall, digital sleep training with somnio was able to both reduce insomnia symptoms and improve sleep. After 8 and 16 weeks of training, there were significant improvements in the measured insomnia severity and in various sleep parameters.
The study, which was conducted between January and July 2023, recruited 56 adult participants who met the criteria for insomnia. This was measured using the Insomnia Severity Index (ISI). The trial participants were randomly assigned to either the digital CBT-I group with somnio (29 people), or the digital sleep monitoring app malio (27 people) as a control group. The group of somnio users received access to CBT-I in digital form, with modules on sleep hygiene, cognitive restructuring, sleep restriction and stimulus control as well as relaxation techniques. The control group was given access to the malio sleep monitoring app, which monitors users’ sleep behavior and provides feedback based on the recorded data, but without therapeutic interventions. An active control group (sleep diary) was therefore chosen, which is also the special feature of the study.
Somnio is the first permanently approved digital health application (DiGA) for sleep disorders that digitally implements CBT-I. The efficacy of somnio has been proven by a randomized controlled trial. Somnio is approved as a Class I medical device and as a digital health application (DiGA) and is fully reimbursed by statutory and many private health insurance companies upon presentation of a prescription.
Mementor DE GmbH develops and distributes digital medical products, such as somnio, in sleep medicine and related areas. The company was originally founded in Switzerland and moved its headquarters to Leipzig in 2020. In 2022, the company was acquired by the ResMed Group.

Source (in German): https://transkript.de/medtech-zwo-artikel/2024/schlaf-app-somnio-zeigt-in-studie-verbesserungen/