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

NCT07470138 | Recruiting

• 1 other identifier: 117/24
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Sleep Disturbance Scale for Children

  Sleep 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

  once at enrolment

Study Arms (1)

one group

Other: follow up

Interventions

follow up OTHER

clinical evaluation as usual

one group

Eligibility Criteria

• Age: 18 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

subjects with ASD aged between 18 months and 60 months

You may qualify if:

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

You may not qualify if:

• \- Subjects with neurologica theraphy

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (2)

IRCCS EW Medea

Bosisio Parini, lc, 23890, Italy

RECRUITING

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Elisa Mani, md

CONTACT

031 877578; elisa.mani@lanostrafamiglia.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: January 8, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

IT (2)