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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05558865
Other study ID # somnovia-RCT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2022
Est. completion date September 18, 2023

Study information

Verified date June 2023
Source Gaia AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 290
Est. completion date September 18, 2023
Est. primary completion date May 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - diagnosis of chronic insomnia - impaired quality of sleep (Insomnia Severity Index Score = 10) Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
somnovia
Participants receive access to the digital health application somnovia

Locations

Country Name City State
Germany GAIA AG Hamburg

Sponsors (3)

Lead Sponsor Collaborator
Gaia AG University Hospital Freiburg, University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Insomnia Severity Index (ISI) 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). 3 months after randomization
Secondary Insomnia Severity Index (ISI) 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). 6 months after randomization
Secondary Patient Health Questionnaire (PHQ-9) The PHQ-9 is a well-validated nine-item self-report questionnaire developed to score each of the nine DSM-IV criteria for major depressive disorder on a 4-point Likert scale, from "0" (not at all) to "3" (nearly every day). 3 months and 6 months after randomization
Secondary Generalized Anxiety Disorder Assessment (GAD-7) The GAD-7 is a self-administered patient questionnaire used as a screening tool and severity measure for generalized anxiety disorder (GAD) 3 months and 6 months after randomization
Secondary Work and Social Assessment Scale (WSAS) WSAS is a 5-item self-report scale to measure the ability to work in regard to physical, mental and social health as well as age group referenced competence for performance. Each item is rated on a 9-point Likert scale from 0 = "not at all impaired" to 8 = "very severely impaired". 3 months and 6 months after randomization
Secondary Responder Rate on Insomnia Severity Index A Responder is defined as a patient with an improvement of > 6 points on the total score of the Insomnia Severity Index from T0 to T1 3 months after randomization
Secondary Remission Rate on Insomnia Severity Index Remission is defined as patients with a total score on the Insomnia Severity Index of < 8 3 months after randomization
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