Actively Recruiting

Age: 18Months - 60Months
All Genders
NCT07470138

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

Led by IRCCS Eugenio Medea · Updated on 2026-03-24

200

Participants Needed

2

Research Sites

100 weeks

Total Duration

On this page

Sponsors

I

IRCCS Eugenio Medea

Lead Sponsor

F

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Months - 60Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Autism Spectrum Disorder (ASD)
  • Age between 18 months and 60 months
Not Eligible

You will not qualify if you...

  • Receiving neurological therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

IRCCS EW Medea

Bosisio Parini, lc, Italy, 23890

Actively Recruiting

2

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, Italy

Actively Recruiting

Loading map...

Research Team

E

Elisa Mani, md

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here