University of Campania Luigi Vanvitelli
Naples, Napoli, 80131, Italy
NCT Number: NCT07122388
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.
This study is active but is not currently recruiting participants.
3 year–18 year
All sexes
Observational
Naples, Napoli, 80131, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Recruitment of subjects with autism spectrum disorder at all developmental ages and of all severity levels.
Recruitment of subjects with autism spectrum disorder at all developmental ages and all severity levels.
Time frame: Baseline (single night recording)
Assessment of sleep architecture parameters scored according to the American Academy of Sleep Medicine (AASM) pediatric criteria.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (single night recording)
The absolute duration of each sleep stage will be calculated in minutes, scored according to AASM pediatric criteria.
Time frame: 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.
Time frame: Baseline
Parent-completed 26-item questionnaire assessing six dimensions of sleep disturbances in children and adolescents over the previous 6 months.
Time frame: Baseline
36-item questionnaire assessing parental distress, parent-child dysfunctional interaction, and perceptions of the child's temperament.
Time frame: Baseline
Structured parent interview assessing qualitative abnormalities in reciprocal social interaction, communication, and restricted/repetitive behaviors.
Time frame: Baseline
Standardized, semi-structured observational assessment used to classify autism severity levels (1, 2, or 3) according to DSM-5 criteria.
Time frame: Baseline
Parent-report questionnaire assessing a wide range of emotional and behavioral problems in children aged 1-5 or 6-18 years.
Time frame: Baseline
Participant age (in years) and sex (male, female).
University of Campania Luigi Vanvitelli
Other
"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"
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