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NCT05558865 | Completed | Insomnia Disorder


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

Gaia AG

Brief 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.

Condition or disease

Insomnia Disorder

Intervention/treatment

somnovia

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 290 participants
Masking: Single
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial
Actual Study Start Date : November 8, 2022
Estimated Primary Completion Date : May 22, 2023
Estimated Study Completion Date : September 18, 2023
Arm Intervention/treatment

Experimental: somnovia

somnovia is a digital health application for people with Insomnia Disorder. Content is continuously adapted to patients' concerns and needs. somnovia is a comprehensive program, which is conceptually and substantially based on the Cognitive Behavioral Therapy for Insomnia (CBT-I) used in patients with Insomnia Disorder. It contains interactive dialogues that can be accessed via computer or smartphone, illustrations, audio recordings and motivating text messages. Techniques to cope with insomnia symptoms (e.g., psychoeducation about causes and basic emotional needs in addition to relevant strategies to improve sleep quality) are conveyed in interactive sequences that are accompanied by audio recordings, illustrations, and worksheets. Patients are also prompted to regularly complete brief symptom severity self-monitoring questionnaires. Optional daily text messages with motivational content accompany the program. The program can be accessed for 365 days after registration.

No Intervention: Care as Usual

Care as Usual: In the CAU control group, participants are free to continue to engage with any treatment they require. However, they will be offered access to somnovia after 6 months post-baseline.

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • diagnosis of chronic insomnia
  • impaired quality of sleep (Insomnia Severity Index Score ≥ 10)
Exclusion Criteria
  • none

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

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Germany,

GAIA AG

Hamburg, Germany, 20144

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