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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorIRCCS Eugenio Medea

About this trial

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.

Eligibility criteria

Qualifiers

Subjects with ASD

aged between 18 months and 60 months

Disqualifiers

None

Trial design

Treatments tested in this trial

  • follow up

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

IRCCS Eugenio Medea

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborator