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临床试验/NCT07470138
NCT07470138招募中不适用

Disturbo Del Sonno in Soggetti Con Disturbi Dello Spettro Dell'Autismo (ASD) in età Prescolare (18-60 Mesi)

IRCCS Eugenio Medea2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Sleep Disturbance Scale for Children

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Months 至 60 Months(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • - Subjects with neurologica theraphy

研究组 & 干预措施

one group

干预措施: follow up (Other)

结局指标

主要结局

Sleep Disturbance Scale for Children

时间窗: once at enrolment

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

次要结局

未报告次要终点

研究者

发起方
IRCCS Eugenio Medea
申办方类型
Other
责任方
Sponsor

研究点 (2)

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