NCT07122388

"Sleep Patterns and EEG Structure in Youth With Autism: Links With Behavior and Parental Stress"

"Retrospective Study on the Evaluation of Sleep Habits, Sleep Macrostructure and Microstructure in Children and Adolescents With Autism Spectrum Disorder: Association With Behavioral Variables and Parental Stress"

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 187 (estimated)
• Sponsor: University of Campania Luigi Vanvitelli · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Accepted

Summary

This retrospective observational study is designed to investigate sleep patterns, as well as both the macrostructure and microstructure of sleep, in a large cohort of children and adolescents diagnosed with Autism Spectrum Disorder (ASD). The study will utilize data derived from overnight polysomnographic recordings, providing objective and comprehensive measures of sleep architecture. The sample consists of 187 patients, aged between 3 and 16 years, whose sleep data were collected over a ten-year period, from 2003 to 2013. In addition to polysomnographic parameters, the study will incorporate a wide range of behavioral and parental stress-related variables. These will be assessed using validated, standardized instruments, including the Sleep Disturbance Scale for Children (SDSC), Autism Diagnostic Interview-Revised (ADI-R), Autism Diagnostic Observation Schedule-2 (ADOS-2), Child Behavior Checklist (CBCL), and the Parenting Stress Index - Short Form (PSI-SF). By integrating objective sleep data with behavioral and psychosocial measures, this study aims to provide a more nuanced understanding of the nature and extent of sleep disturbances in individuals with ASD. Particular attention will be paid to identifying potential correlations between specific sleep alterations (e.g., changes in sleep efficiency, REM latency, arousals, or cyclic alternating patterns) and behavioral symptoms or parental stress profiles. Ultimately, the findings are expected to contribute to the development of more precise and individualized diagnostic frameworks, as well as inform evidence-based therapeutic strategies. These insights could be of considerable clinical relevance, given the high prevalence of sleep disorders in the ASD population and their significant impact on daytime functioning, emotional regulation, and family quality of life.

Conditions

• Sleep Disorder (Disorder)
• Autism Spectrum Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Questionnaires about autism spectrum disorders and sleep and PSG.	Recruitment of subjects with autism spectrum disorder at all developmental ages and of all severity levels.
DIAGNOSTIC_TEST	ADOS-2, ADI-R, SRS-2, PSG	Recruitment of subjects with autism spectrum disorder at all developmental ages and all severity levels.

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-10-30
• Completion: 2025-08-10
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: Italy