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Sleep Disorder (Disorder)NCT07122388

"Sleep Patterns and EEG Structure in Youth With Autism: Links With Behavior and Parental Stress"

An observational study of Sleep Disorder (Disorder) and Autism Spectrum Disorder, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 3 to 18 yearsHealthy volunteers can take part
What is being tested?
Questionnaires about autism spectrum disorders and sleep and PSG. and ADOS-2, ADI-R, SRS-2, PSG
How many people
187 participants
Where
1 siteItaly
Study dates
1 Jun 2020to 10 Aug 2025
How long will I take part?
2 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Children and adolescents with autism spectrum disorder

Who may be able to join

  • 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

Who cannot join

  • Neuropsychiatric disorders other than autism
  • Epilepsy
  • Age under 3 years or over 18 years
  • Comorbidity with another severe psychiatric disorder (e.g., psychosis, schizophrenia)

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University of Campania Luigi Vanvitelli

    Naples, Napoli, 80131

Other trials in Italy

About this study

Official title: "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"

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).

Read more

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.

Being tested
Questionnaires about autism spectrum disorders and sleep and PSG., ADOS-2, ADI-R, SRS-2, PSG
Keywords
NREM sleep instability, CAP analysis, CBCL, ADOS-2, ADI-R, PSI-SF, Polysomnography
Medical subject headings
Sleep Wake Disorders, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • ADOS-2, ADI-R, SRS-2, PSGDiagnostic test

    Recruitment of subjects with autism spectrum disorder at all developmental ages and all severity levels.

Study groups in NCT07122388
Study groupRoleWhat they receive
Autism spectrum disorderSubjects with SRS-2 positive screening and confirmed by ADOS-2 evaluation
Receives: Diagnostic Test: Questionnaires about autism spectrum disorders and sleep and PSG.; Diagnostic Test: ADOS-2, ADI-R, SRS-2, PSG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (single night recording)

  2. 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.

    Measured: Baseline (single night recording)

  3. 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.

    Measured: Baseline (single night recording)

  4. 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.

    Measured: Baseline (single night recording)

  5. 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.

    Measured: Baseline (single night recording)

  6. Duration of N1, N2, N3, and REM stages measured in minutes by overnight polysomnography.

    The absolute duration of each sleep stage will be calculated in minutes, scored according to AASM pediatric criteria.

    Measured: Baseline (single night recording)

Secondary outcomes (7)

  1. 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.

    Measured: Baseline (single night recording)

  2. Sleep Habits - Sleep Disorders Scale for Children (SDSC)

    Parent-completed 26-item questionnaire assessing six dimensions of sleep disturbances in children and adolescents over the previous 6 months.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. Social Impairment - Autism Diagnostic Interview-Revised (ADI-R)

    Structured parent interview assessing qualitative abnormalities in reciprocal social interaction, communication, and restricted/repetitive behaviors.

    Measured: Baseline

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: Baseline

  7. Demographics - Age and Sex

    Participant age (in years) and sex (male, female).

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2025
  2. Study start1 Jun 2020
  3. Primary completion30 Oct 2020
  4. Study completion10 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
187 participants (estimated)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07122388
Sponsor's protocol ID
217
Status last verified
Aug 2025
First submitted
30 Jul 2025
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32182969

  • 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.

    PubMed 37909101

  • 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.

    PubMed 35165244

  • 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.

    PubMed 37643569

  • 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.

    PubMed 39779841

  • 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.

    PubMed 40742672

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Disorder (Disorder) and Autism Spectrum Disorder, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Baseline (single night recording)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07122388, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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