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Can a bedtime therapy help kids with insomnia sleep better?

NCT ID NCT07048340

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

7 to 11 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Tel Aviv University

    RECRUITING

    Tel Aviv, Israel, 4641729, Israel

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