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

Sponsored by Gaia AG

About this trial

Last updated 2 years ago

Study ID

somnovia-RCT

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- diagnosis of chronic insomnia

- impaired quality of sleep (Insomnia Severity Index Score ≥ 10)

No

Exclusion Criteria

- none

Locations

Location

Status