New app aims to cure insomnia from your phone
NCT ID NCT07289217
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a mobile app called SleepQ can reduce insomnia symptoms in adults. The app provides a 12-week digital cognitive behavioral therapy program, including sleep scheduling and relaxation techniques. Eighty participants will be randomly assigned to use the app plus usual care, or just usual care alone. The main goal is to see if the app improves sleep quality after 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SleepQ digital cognitive behavioral therapy (dCBT-I) mobile app
- What this could lead to
- If it works, this could offer a convenient, app-based treatment option for insomnia that people can use from home.
- What could go wrong
- This is a small pilot trial with only 80 participants, so results may not apply to everyone. The app requires an iPhone with iOS 18 and German language skills, limiting who can use it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult patients ≥18 years old * Confirmed current diagnosis of F51.0 Nonorganic insomnia or G47.0 Sleep disorders * Possession of a mobile device with internet connection (must be run on iOS software, minimum version 18) with internet connection * Sufficient German language proficiency required for the correct use of the intervention and the mobile device * Personal e-mail address for registration * Willing and able to provide written informed consent * Insomnia Severity Index (ISI) socre of 15 or higher, indicating clinically relevant symptoms of insomnia * Registered with a GP, sleep specialist or other health care professional Exclusion Criteria: * Use of a digital interventioan for insomnia treatment in the past 6 months or planned use of comparable digital intervention during the study period * PHQ-9 score at screening ≥ 20 and/or item 9 f PHQ-9 ≥ 1 * GAD-7 score at screening ≥ 15 * Intermittent use and/or recent initiation (\< 3m) or planned use of insomnia specific prescription-only pharmacological therapy * Intermittent use and/or recent initiation (\< 3m) or planned use of a psychotropic during the study period which has recognised potential effects on insomnia * Participation in CBT or other psychotherapy to treat sleep disorders in the last 6 months (outpatient, inpatient) or planned start during the study period * Known history or diagnosis of substance or alchol abuse or dependence within 12 months prior to screening (diagnosis of F10-F19, excluding F17.1 and F17.2) * Current or planned participation in other clinical trials during the study period * Working in shifts * Currently pregnant or planning to become pregnant within the next 3 months * Any surgical procedure that was scheduled, planned, or conducted within the timeframe of the study (minor outpatient procedures under local anaesthetic or with no anesthetic are permitted) * Diagnosis of epilepsy * Presence of serious mental illness, such as (schizophrenia F 20.-, acute transient psychotic disorders F23.-, active manic episode F30.-, bipolar disorder F31.-, severe depression F32.3, F33.3) * Other diseases (such as acute or severe cardiac diseases, acute or severe respiratory diseases, acute or severe gastrointestinal diseases), conditions or therapies which, in the opinion of the investigator, could confound the study results or contraindicate participation. * Acute suicidal thoughts or intentions within the past 12 months * Presence of obstructive sleep apnea, restless legs syndrome, parasomnia, and other sleep behavior problem
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Berlin Medical Association (Ärztekammer Berlin)
Berlin, 10969, Germany
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Other studies related to the condition(s) this trial covers.
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- Can fixing insomnia help heavy drinkers cut back?
- Can a sleep therapy program help control blood sugar in older diabetes patients?