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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autism spectrum disorder | Subjects with SRS-2 positive screening and confirmed by ADOS-2 evaluation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Microstructural Sleep Parameters - Cyclic Alternating Pattern (CAP) Analysis from Overnight Polysomnography | Quantitative analysis of sleep microstructure, including CAP rate, phase A subtypes, and non-CAP periods, according to Terzano et al. methodology. | Baseline (single night recording) |
| Sleep Habits - Sleep Disorders Scale for Children (SDSC) |
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Inclusion Criteria:
Exclusion Criteria:
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Children and adolescents with autism spectrum disorder
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Campania Luigi Vanvitelli | Naples | Napoli | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32182969 | Result | 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. | |
| 37909101 | Result | 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. |
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| ADOS-2, ADI-R, SRS-2, PSG | Diagnostic Test | Recruitment of subjects with autism spectrum disorder at all developmental ages and all severity levels. |
|
The absolute duration of each sleep stage will be calculated in minutes, scored according to AASM pediatric criteria. |
| Baseline (single night recording) |
Parent-completed 26-item questionnaire assessing six dimensions of sleep disturbances in children and adolescents over the previous 6 months. |
| Baseline |
| Parental Stress - Parenting Stress Index Short Form (PIS-SF) | 36-item questionnaire assessing parental distress, parent-child dysfunctional interaction, and perceptions of the child's temperament. | Baseline |
| Social Impairment - Autism Diagnostic Interview-Revised (ADI-R) | Structured parent interview assessing qualitative abnormalities in reciprocal social interaction, communication, and restricted/repetitive behaviors. | Baseline |
| Autism Severity - Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) | Standardized, semi-structured observational assessment used to classify autism severity levels (1, 2, or 3) according to DSM-5 criteria. | Baseline |
| Behavioral Assessment - Child Behavior Checklist (CBCL; Age-Specific Parent-Report Forms) | Parent-report questionnaire assessing a wide range of emotional and behavioral problems in children aged 1-5 or 6-18 years. | Baseline |
| Demographics - Age and Sex | Participant age (in years) and sex (male, female). | Baseline |
| 35165244 | Result | 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. |
| 37643569 | Result | 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. |
| 39779841 | Result | 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. |
| 40742672 | Result | 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. |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
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| ID | Term |
|---|---|
| D012890 | Sleep |
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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