Can a bedtime therapy help kids with insomnia sleep better?
NCT ID NCT07048340
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a type of talk therapy called cognitive-behavioral therapy for insomnia (CBT-I) in children aged 7 to 11 who have trouble sleeping. Some children will get CBT-I that includes a technique called sleep restriction therapy, while others get CBT-I without it, and a third group will be placed on a waitlist. The goal is to see if adding sleep restriction therapy improves sleep quality and reduces insomnia symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cognitive Behavioral Therapy for Insomnia (CBT-I) with or without sleep restriction therapy
- What this could lead to
- If successful, this could show that adding sleep restriction therapy makes CBT more effective for treating childhood insomnia.
- What could go wrong
- This is a relatively small, early-stage trial (120 children) and results may not apply to all kids. The therapy requires active participation from both child and parent, which may limit real-world success.
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 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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7 to 11 years
- 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: * Child aged 7-11 years * Parents aged over 18 years * Child meets the International Classification of Sleep Disorders - Third Edition (ICSD-3) criteria for chronic insomnia disorder with sleep difficulties occurring at least 3 times a week and lasting at least 3 months (Insomnia diagnosis will be determined during a clinical interview). Exclusion Criteria: * Child receiving concurrent CBT treatment for sleep or anxiety disorders. * Child diagnosed with a medical sleep problem (e.g., OSA, RLS) * Significant health or neurodevelopmental problems (e.g., intellectual disability) * Current psychotropic medications, or sleep aid medications * Lack of Hebrew reading and writing * Total sleep time that is shorter than 6 hours on average per night at baseline
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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 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
Locations
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Tel Aviv University
RECRUITINGTel Aviv, Israel, 4641729, Israel
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