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

Insomnia Disorder Clinical Trial

Official title:

Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05558865
• Other study ID #: somnovia-RCT
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

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