Clinical trial Recruiting at 2 sites Observational Ages 18 Months to 60 Months

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 typeObservational
Ages18 Months to 60 Months
SexAll
Enrollment200 (estimated)
SponsorIRCCS Eugenio Medea
Academic / other
Locations2 sites (Bosisio Parini, lc and 1 other locations)
StatusRecruiting
StartedJanuary 8, 2025
Main results expectedDecember 15, 2026
Study endsDecember 15, 2026
Registry record updatedMarch 24, 2026
Trial IDNCT07470138 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.