"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"
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Sleep Efficiency measured as a percentage by overnight polysomnography
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Neuropsychiatric disorders other than autism
- •Age under 3 years or over 18 years
- •Comorbidity with another severe psychiatric disorder (e.g., psychosis, schizophrenia)
结局指标
主要结局
Sleep Efficiency measured as a percentage by overnight polysomnography
时间窗: 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
时间窗: 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.
时间窗: 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.
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Behavioral Assessment - Child Behavior Checklist (CBCL; Age-Specific Parent-Report Forms)(Baseline)
- Demographics - Age and Sex(Baseline)
研究者
Marco Carotenuto
Full Professor of Child Neuropsychiatry
University of Campania Luigi Vanvitelli