Sleep problems in preschool children with autism (18–60 months)
Official title: Disturbo Del Sonno in Soggetti Con Disturbi Dello Spettro Dell'Autismo (ASD) in età Prescolare (18-60 Mesi)
Run by IRCCS Eugenio Medea · NCT07470138 · Data updated 2026-11-12
This study will see how common sleep problems are and how they relate to development in preschool children aged 18–60 months with autism.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Months to 60 Months |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 2 sites (Bosisio Parini, lc and 1 other locations) |
| Status | Recruiting |
| Started | January 8, 2025 |
| Main results expected | December 15, 2026 |
| Study ends | December 15, 2026 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT07470138 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Preschool children aged 18–60 months with a diagnosed autism spectrum disorder who can attend follow-up visits at the participating centers and are not receiving concurrent neurological therapy.
✕Probably not a fit
Children outside the 18–60 month age range, children without an ASD diagnosis, or those currently on neurological therapy (per the study exclusion) 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 observational project will collect routine clinical and follow-up data on sleep patterns in children with autism aged 18 to 60 months without adding tests beyond standard care. Families will attend participating Italian centers for clinical visits and follow-up, and clinicians will document sleep histories and any treatments recorded in usual practice. The study aims to describe the prevalence and patterns of sleep disturbances and their connections to early cognitive and socioemotional development. Results are intended to inform earlier identification and more targeted management of sleep problems in this age group.
Why it matters
Potential benefit: If successful, the findings could help clinicians spot sleep problems earlier in young children with autism and guide timely treatment to protect cognitive and social development.
How similar studies have gone: Prior research has consistently reported high rates of sleep problems in children with ASD and links to developmental outcomes, so this observational approach builds on an established evidence base.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with ASD * aged between 18 months and 60 months Exclusion Criteria: \- Subjects with neurologica theraphy
Where it's running
-
IRCCS EW Medea
Bosisio Parini, lc, Italy Recruiting -
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy Recruiting
Study contacts
- Study coordinator: Elisa Mani, md
- Email: elisa.mani@lanostrafamiglia.it
- Phone: 031 877578
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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.