Insomnia DisorderNCT05558865
Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia)
A study testing somnovia in people with Insomnia Disorder, run by Gaia AG at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- somnovia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteGermany
- Study dates
- 8 Nov 2022to 18 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of chronic insomnia
- impaired quality of sleep (Insomnia Severity Index Score ≥ 10)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial
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
- Being tested
- somnovia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somnoviaBehavioural
Participants receive access to the digital health application somnovia
| Study group | Role | What they receive |
|---|---|---|
| somnovia | Experimental | 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. Receives: Behavioral: somnovia |
| Care as Usual | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months after randomization
Secondary outcomes (6)
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).
Measured: 6 months after randomization
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).
Measured: 3 months and 6 months after randomization
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)
Measured: 3 months and 6 months after randomization
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".
Measured: 3 months and 6 months after randomization
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
Measured: 3 months after randomization
Remission Rate on Insomnia Severity Index
Remission is defined as patients with a total score on the Insomnia Severity Index of < 8
Measured: 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start8 Nov 2022
- Primary completion22 May 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Schleswig-Holstein, University Hospital Freiburg
- Responsible party
- Sponsor
- Investigators
- Robert Göder, Prof. Dr., Principal investigator, Christian-Albrechts-Universität zu Kiel, Clinic for Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558865
- Sponsor's protocol ID
- somnovia-RCT
- Status last verified
- Jun 2023
- First submitted
- 26 Sep 2022
- Last updated
- 25 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Betz LT, Goder R, Jacob GA, Riemann D. Targeting hyperarousal to improve sleep: A network intervention analysis of a digital intervention for insomnia. Behav Res Ther. 2026 Aug;203:105075. doi: 10.1016/j.brat.2026.105075. Epub 2026 May 20.
PubMed 42184726
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05558865
- Acronym / sponsor ID
- somnovia-RCT
- Conditions
- Insomnia Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Schleswig-Holstein, University Hospital Freiburg
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| somnovia | Experimental | Behavioral: somnoviasomnovia 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. |
| Care as Usual | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of chronic insomnia
- impaired quality of sleep (Insomnia Severity Index Score ≥ 10)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somnoviaParticipants receive access to the digital health application somnovia | Behavioural | somnovia |
Primary outcome
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).
6 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: 6 months after randomization
Patient Health Questionnaire (PHQ-9)
Time frame: 3 months and 6 months after randomization
Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: 3 months and 6 months after randomization
Work and Social Assessment Scale (WSAS)
Time frame: 3 months and 6 months after randomization
Responder Rate on Insomnia Severity Index
Time frame: 3 months after randomization
Remission Rate on Insomnia Severity Index
Time frame: 3 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 42184726Betz LT, Goder R, Jacob GA, Riemann D. Targeting hyperarousal to improve sleep: A network intervention analysis of a digital intervention for insomnia. Behav Res Ther. 2026 Aug;203:105075. doi: 10.1016/j.brat.2026.105075. Epub 2026 May 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Göder, Prof. Dr. principal investigator
Christian-Albrechts-Universität zu Kiel, Clinic for Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing somnovia in people with Insomnia Disorder, run by Gaia AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: 3 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05558865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.