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Sleep Disturbance in Subjects With Autism Spectrum Disorders (ASD) in Preschool Age (18-60 Months)

Disturbo Del Sonno in Soggetti Con Disturbi Dello Spettro Dell'Autismo (ASD) in età Prescolare (18-60 Mesi)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07470138
Enrollment
200
Registered
2026-03-13
Start date
2025-01-08
Completion date
2026-12-15
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Brief summary

An observational study is one that aims to collect data from routine clinical practice, without altering a patient's standard diagnostic and therapeutic pathway (no additional instrumental or laboratory tests beyond those performed in clinical practice are envisaged). The overall objective of this study is to investigate sleep disorders in preschool-aged children with Autism Spectrum Disorder. Sleep plays a key role in early brain development. The prevalence of sleep disorders in childhood is reported to be between 10 and 50%, with a prevalence of up to 86% in children with neurodevelopmental disorders. Over the past few decades, numerous studies have demonstrated a significant bidirectional connection between sleep problems and various areas of child development. Therefore, early identification of sleep disorders in childhood is essential for adequate treatment and prevention of negative cognitive and socioemotional impacts. Recent studies have demonstrated a hypothetical role for vitamin D and iron in regulating sleep. The objectives of the study are to describe sleep disturbances in a group of preschool-aged subjects with ASD (18-60 months), to measure blood ferritin and vitamin D levels, and to assess a possible correlation with specific subtypes of sleep disturbances. Given the impact that sleep disturbances have on various areas of children's development, secondary objectives include assessing a possible positive correlation between the severity of sleep disturbances and symptoms related to Autism Spectrum Disorder and/or other psychiatric comorbidities.

Interventions

OTHERfollow up

clinical evaluation as usual

Sponsors

IRCCS Eugenio Medea
Lead SponsorOTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Months to 60 Months
Healthy volunteers
No

Inclusion criteria

* Subjects with ASD * aged between 18 months and 60 months

Exclusion criteria

\- Subjects with neurologica theraphy

Design outcomes

Primary

MeasureTime frameDescription
Sleep Disturbance Scale for Childrenonce at enrolmentSleep disturbances will be assessed using the Sleep Disturbance Scale for Children (SDSC) in the 3-6 year version and the 6 months-3 years version

Countries

Italy

Contacts

CONTACTElisa Mani, md
elisa.mani@lanostrafamiglia.it031 877578

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026