Cognitive-behavioral therapy with and without sleep restriction for insomnia in children aged 7-11
Official title: The Role of Sleep Restriction Therapy in Cognitive-behavioral Therapy for Insomnia in School-aged Children: A Randomized Controlled Trial
Run by Tel Aviv University · NCT07048340 · Data updated 2026-11-12
This project will test whether adding sleep restriction to CBT-I helps children aged 7-11 with chronic insomnia sleep better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 7 Years to 11 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Tel Aviv University Academic / other |
| Locations | 1 site (Tel Aviv, Israel) |
| Status | Recruiting |
| Started | July 10, 2025 |
| Main results expected | January 1, 2029 |
| Study ends | December 1, 2029 |
| Registry record updated | September 18, 2025 |
| Trial ID | NCT07048340 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 7–11 who meet ICSD-3 criteria for chronic insomnia (symptoms ≥3 nights/week for ≥3 months), average at least 6 hours of sleep per night at baseline, have parents over 18, can read and write Hebrew, and are not on sleep or psychotropic medications or receiving concurrent CBT.
✕Probably not a fit
Children with medical sleep disorders (e.g., OSA, RLS), significant neurodevelopmental or health problems, those on sleep/psychotropic medications, non-Hebrew speakers, or those averaging under 6 hours of sleep per night are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, dismantling trial will assign children 7-11 with chronic insomnia to one of three groups: full CBT-I (including sleep restriction), CBT-I without sleep restriction, or a waitlist control. Sleep and insomnia outcomes will be measured with actigraphy, sleep diaries, a diagnostic interview, and parent/child questionnaires at baseline, mid-treatment, post-treatment, and 3-month follow-up, and some measures (e.g., child motivation) will be collected after each session. The design specifically tests the incremental benefit of sleep restriction therapy and examines mediators (pre-sleep hyperarousal and parental over-accommodation) and a moderator (child motivation). The trial aims to clarify which CBT-I components drive clinical change in school-aged children and inform parent-involved treatment strategies.
Why it matters
Potential benefit: If successful, the study could show whether including sleep restriction improves CBT-I outcomes for children and help clinicians deliver a more effective, targeted treatment.
How similar studies have gone: CBT-I and sleep restriction have strong evidence in adults and some supportive data in older youth, but CBT-I in school-aged children and the specific added value of sleep restriction remain largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Tel Aviv University
Tel Aviv, Israel, Israel Recruiting
Study contacts
- Study coordinator: Michal Kahn, PhD
- Email: michalkahn10@gmail.com
- Phone: +972544682588
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.