NCT05558865

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Gaia AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia Disorder

Interventions

Type	Name	Description
BEHAVIORAL	somnovia	Participants receive access to the digital health application somnovia

Timeline

• Start date: 2022-11-08
• Primary completion: 2023-05-22
• Completion: 2023-09-18
• First posted: 2022-09-28
• Last updated: 2023-09-25

Locations

1 site across 1 country: Germany