Sleep problems in preschool children with autism (18–60 months)
Disturbo Del Sonno in Soggetti Con Disturbi Dello Spettro Dell'Autismo (ASD) in età Prescolare (18-60 Mesi)
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Months to 60 Months |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 2 sites (Bosisio Parini, lc and 1 other locations) |
| Trial ID | NCT07470138 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with ASD * aged between 18 months and 60 months Exclusion Criteria: \- Subjects with neurologica theraphy
Where this trial is running
Bosisio Parini, lc and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.