Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia Disorder
- Sponsor
- Gaia AG
- Enrollment
- 290
- Locations
- 1
- Primary Endpoint
- Insomnia Severity Index (ISI)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •diagnosis of chronic insomnia
- •impaired quality of sleep (Insomnia Severity Index Score ≥ 10)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Insomnia Severity Index (ISI)
Time Frame: 3 months after randomization
The ISI is a 7-item patient-reported outcome measure (PROM) assessing the nature, severity, and impact of insomnia on a 5-point Likert scale to rate each item from 0 (no problem) to 4 (very severe problem).
Secondary Outcomes
- Insomnia Severity Index (ISI)(6 months after randomization)
- Patient Health Questionnaire (PHQ-9)(3 months and 6 months after randomization)
- Responder Rate on Insomnia Severity Index(3 months after randomization)
- Remission Rate on Insomnia Severity Index(3 months after randomization)
- Generalized Anxiety Disorder Assessment (GAD-7)(3 months and 6 months after randomization)
- Work and Social Assessment Scale (WSAS)(3 months and 6 months after randomization)