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

NCT07122388 | Active Not Recruiting

• 1 other identifier: 217
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NREM sleep instability; CAP analysis; CBCL; ADOS-2; ADI-R; PSI-SF; Polysomnography

Outcome Measures

Primary Outcomes (6)

• This retrospective observational study aims to evaluate sleep habits, as well as sleep macrostructure and microstructure, in a large cohort of children and adolescents with Autism Spectrum Disorder (ASD) through overnight polysomnographic assessment.

  Assessment of sleep architecture parameters scored according to the American Academy of Sleep Medicine (AASM) pediatric criteria.

  Baseline (single night recording)

• Total Sleep Time (TST) measured in minutes by overnight polysomnography

  otal sleep time will be calculated from a single-night video-polysomnography recording, scored according to American Academy of Sleep Medicine (AASM) pediatric criteria.

  Baseline (single night recording)

• Sleep Latency measured in minutes by overnight polysomnography

  Sleep latency will be calculated as the time from lights-off to the first epoch of any sleep stage, scored according to AASM pediatric criteria.

  Baseline (single night recording)

• Sleep Efficiency measured as a percentage by overnight polysomnography

  Sleep efficiency will be calculated as the ratio of total sleep time to total time in bed, expressed as a percentage, scored according to AASM pediatric criteria.

  Baseline (single night recording)

• Percentage of time spent in N1, N2, N3, and REM stages measured by overnight polysomnography

  The proportion of total sleep time spent in each sleep stage will be calculated and expressed as a percentage, scored according to AASM pediatric criteria.

  Baseline (single night recording)

• Duration of N1, N2, N3, and REM stages measured in minutes by overnight polysomnography.

  The absolute duration of each sleep stage will be calculated in minutes, scored according to AASM pediatric criteria.

  Baseline (single night recording)

Secondary Outcomes (7)

• Microstructural Sleep Parameters - Cyclic Alternating Pattern (CAP) Analysis from Overnight Polysomnography

  Baseline (single night recording)

• Sleep Habits - Sleep Disorders Scale for Children (SDSC)

  Baseline

• Parental Stress - Parenting Stress Index Short Form (PIS-SF)

  Baseline

• Social Impairment - Autism Diagnostic Interview-Revised (ADI-R)

  Baseline

• Autism Severity - Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)

  Baseline

Study Arms (1)

Autism spectrum disorder

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

Diagnostic Test: Questionnaires about autism spectrum disorders and sleep and PSG.; Diagnostic Test: ADOS-2, ADI-R, SRS-2, PSG

Interventions

Questionnaires about autism spectrum disorders and sleep and PSG. DIAGNOSTIC_TEST

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

Autism spectrum disorder

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

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

Autism spectrum disorder

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with autism spectrum disorder

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania Luigi Vanvitelli

Napoli, Napoli, 80131, Italy

Location

Related Publications (6)

• Marotta R, Risoleo MC, Messina G, Parisi L, Carotenuto M, Vetri L, Roccella M. The Neurochemistry of Autism. Brain Sci. 2020 Mar 13;10(3):163. doi: 10.3390/brainsci10030163.

  PMID: 32182969 BACKGROUND

• Voci A, Mazzone L, De Stefano D, Valeriani M, Bruni O, Moavero R. Restless sleep disorder in a sample of children and adolescents with autism spectrum disorder: preliminary results from a case series. J Clin Sleep Med. 2024 Mar 1;20(3):427-432. doi: 10.5664/jcsm.10902.

  PMID: 37909101 BACKGROUND

• Belli A, Breda M, Di Maggio C, Esposito D, Marcucci L, Bruni O. Children with neurodevelopmental disorders: how do they sleep? Curr Opin Psychiatry. 2022 Sep 1;35(5):345-351. doi: 10.1097/YCO.0000000000000790. Epub 2022 Feb 15.

  PMID: 35165244 BACKGROUND

• Bernardi K, Prono F, Bruni G, Panerai S, Ferri R, Bruni O. Sleep disturbances in subjects with autism spectrum disorder: A parental perspective. Sleep Med. 2023 Oct;110:220-224. doi: 10.1016/j.sleep.2023.08.020. Epub 2023 Aug 23.

  PMID: 37643569 BACKGROUND

• Bruni O, Breda M, Mammarella V, Mogavero MP, Ferri R. Sleep and circadian disturbances in children with neurodevelopmental disorders. Nat Rev Neurol. 2025 Feb;21(2):103-120. doi: 10.1038/s41582-024-01052-9. Epub 2025 Jan 8.

  PMID: 39779841 BACKGROUND

• Scahill L, Johnson CR, Wenzell ML, Barto LM, Mulligan A, Williams AT, Johnson LM, Gillespie SE, Lecavalier L. Clinical and Demographic Correlates of Insomnia Symptoms in Children with Autism Spectrum Disorder. J Autism Dev Disord. 2025 Jul 31. doi: 10.1007/s10803-025-06944-3. Online ahead of print. No abstract available.

  PMID: 40742672 BACKGROUND

MeSH Terms

Conditions

Sleep Wake Disorders; Autism Spectrum Disorder

Interventions

Sleep; Polysomnography

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Child Neuropsychiatry

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 14, 2025
• Study Start: June 1, 2020
• Primary Completion: October 30, 2020
• Study Completion: August 10, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)