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+ Years
All
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?
Inclusion Criteria
- diagnosis of chronic insomnia
- impaired quality of sleep (Insomnia Severity Index Score ≥ 10)
Exclusion Criteria
- none