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Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia)

Insomnia Disorder Clinical Trial

Official title:
Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial

Clinical Trial Summary

The trial aims to evaluate the effectiveness of a novel digital health application (somnovia), which was designed to increase sleep quality in persons with insomnia disorder. Therefore, 290 people with insomnia disorder will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment for insomnia disorder and are offered access to somnovia after a delay of 6 months (i.e., Care-as-Usual [CAU]), or (2) to a treatment group that immediately receives 6-month access to somnovia and may also use CAU. The primary outcome measure is the score of the Insomnia Severity Index (ISI), collected at three months post-baseline.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05558865
Study type Interventional
Source Gaia AG
Contact
Status Completed
Phase N/A
Start date November 8, 2022
Completion date September 18, 2023
View Details
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