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NCT07470138
Sleep Disturbance in Subjects With Autism Spectrum Disorders (ASD) in Preschool Age (18-60 Months)
trial testing follow up in Autism Spectrum Disorder in 200 participants. Currently enrolling.
15 December 2026
Quick facts
| Lead sponsor | IRCCS Eugenio Medea |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 8 January 2025 |
| Primary completion | 15 December 2026 |
| Estimated completion | 15 December 2026 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- follow up
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
Sponsor
IRCCS Eugenio Medea — full company profile →
Who can join
Adults 18 Months to 60 Months, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07470138
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other IRCCS Eugenio Medea trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07470138 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS Eugenio Medea
- Last refreshed: 24 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07470138.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing