"Sleep Patterns and EEG Structure in Youth With Autism: Links With Behavior and Parental Stress"
- Conditions
- Sleep Disorder (Disorder)Autism Spectrum Disorder
- Registration Number
- NCT07122388
- Lead Sponsor
- University of Campania Luigi Vanvitelli
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 187
- 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
- Neuropsychiatric disorders other than autism
- Epilepsy
- Age under 3 years or over 18 years
- Comorbidity with another severe psychiatric disorder (e.g., psychosis, schizophrenia)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep Efficiency measured as a percentage by overnight polysomnography Baseline (single night recording) 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.
Percentage of time spent in N1, N2, N3, and REM stages measured by overnight polysomnography Baseline (single night recording) 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.
Duration of N1, N2, N3, and REM stages measured in minutes by overnight polysomnography. Baseline (single night recording) The absolute duration of each sleep stage will be calculated in minutes, scored according to AASM pediatric criteria.
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. Baseline (single night recording) Assessment of sleep architecture parameters scored according to the American Academy of Sleep Medicine (AASM) pediatric criteria.
Total Sleep Time (TST) measured in minutes by overnight polysomnography Baseline (single night recording) otal sleep time will be calculated from a single-night video-polysomnography recording, scored according to American Academy of Sleep Medicine (AASM) pediatric criteria.
Sleep Latency measured in minutes by overnight polysomnography Baseline (single night recording) 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.
- Secondary Outcome Measures
Name Time Method Microstructural Sleep Parameters - Cyclic Alternating Pattern (CAP) Analysis from Overnight Polysomnography Baseline (single night recording) Quantitative analysis of sleep microstructure, including CAP rate, phase A subtypes, and non-CAP periods, according to Terzano et al. methodology.
Sleep Habits - Sleep Disorders Scale for Children (SDSC) Baseline Parent-completed 26-item questionnaire assessing six dimensions of sleep disturbances in children and adolescents over the previous 6 months.
Parental Stress - Parenting Stress Index Short Form (PIS-SF) Baseline 36-item questionnaire assessing parental distress, parent-child dysfunctional interaction, and perceptions of the child's temperament.
Social Impairment - Autism Diagnostic Interview-Revised (ADI-R) Baseline Structured parent interview assessing qualitative abnormalities in reciprocal social interaction, communication, and restricted/repetitive behaviors.
Autism Severity - Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) Baseline Standardized, semi-structured observational assessment used to classify autism severity levels (1, 2, or 3) according to DSM-5 criteria.
Behavioral Assessment - Child Behavior Checklist (CBCL; Age-Specific Parent-Report Forms) Baseline Parent-report questionnaire assessing a wide range of emotional and behavioral problems in children aged 1-5 or 6-18 years.
Demographics - Age and Sex Baseline Participant age (in years) and sex (male, female).
Trial Locations
- Locations (1)
University of Campania Luigi Vanvitelli
🇮🇹Napoli, Italy
University of Campania Luigi Vanvitelli🇮🇹Napoli, Italy