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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2025-08-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Disorder (Disorder) Autism Spectrum Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Autism spectrum disorder

Subjects with SRS-2 positive screening and confirmed by ADOS-2 evaluation

Questionnaires about autism spectrum disorders and sleep and PSG.

Intervention Type DIAGNOSTIC_TEST

Recruitment of subjects with autism spectrum disorder at all developmental ages and of all severity levels.

ADOS-2, ADI-R, SRS-2, PSG

Intervention Type DIAGNOSTIC_TEST

Recruitment of subjects with autism spectrum disorder at all developmental ages and all severity levels.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

ADOS-2, ADI-R, SRS-2, PSG

Recruitment of subjects with autism spectrum disorder at all developmental ages and all severity levels.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Autism Spectrum Disorder
* Age: 3-18 years
* Sex: Both male and female
* Individuals with Autism Spectrum Disorder, including both verbal and non-verbal subjects
* Individuals with Autism Spectrum Disorder, with or without a comorbid genetic syndrome or other neurodevelopmental disorders

Exclusion Criteria

* Neuropsychiatric disorders other than autism
* Epilepsy
* Age under 3 years or over 18 years
* Comorbidity with another severe psychiatric disorder (e.g., psychosis, schizophrenia)

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes