Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Diagnosis of Autism Spectrum Disorder (ASD)
- Age between 18 months and 60 months
You will not qualify if you...
- Receiving neurological therapy
AI-Screening
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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
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
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