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

NCT05558865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2023-09-25

No results posted yet for this study

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

BEHAVIORAL

somnovia

Participants receive access to the digital health application somnovia

Sponsors & Collaborators

  • University Hospital Schleswig-Holstein

    collaborator OTHER

  • University Hospital Freiburg

    collaborator OTHER

  • Gaia AG

    lead INDUSTRY

Principal Investigators

  • Robert Göder, Prof. Dr. · Christian-Albrechts-Universität zu Kiel, Clinic for Psychiatry and Psychotherapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-08
Primary Completion
2023-05-22
Completion
2023-09-18

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05558865 on ClinicalTrials.gov