NCT07122388Active, not recruiting
"Sleep Patterns and EEG Structure in Youth With Autism: Links With Behavior and Parental Stress"
"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"
Source: ClinicalTrials.gov · Last updated 14 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 187 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 1 Jun 2020
- Primary completion date
- 30 Oct 2020
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Diseases
- Autism
- NCT number
- NCT07122388
What you commit to
- Study type: Observational
- Planned participants: 187
- From 1 Jun 2020 to the primary completion date, 30 Oct 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Neuropsychiatric disorders other than autism
- Epilepsy
- Comorbidity with another severe psychiatric disorder (e.g., psychosis, schizophrenia)
Age
- Age under 3 years or over 18 years
Who the study is looking for
- 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
Age in the registry: 3 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Campania "Luigi Vanvitelli" Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.