ClinicalTrials.gov record NCT06877715

Autistic Symptomatology and Sensory Profile in Children With Prader-Willi Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Autistic Symptomatology and Sensory Profile in Children With Prader-Willi Syndrome

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age3 years old to 16 years old
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study evaluates autistic symptoms and sensory profiles in children with genetically confirmed Prader‑Willi syndrome. Children undergo standardized autism assessments, sensory testing, behavioral and cognitive measures, and parent questionnaires over assessments completed within 1–3 days. The study also examines whether early oxytocin treatment (if given in childhood) is associated with differences in these profiles.

What it is studying. The study aims to describe how common and how specific autistic symptoms are in children with Prader‑Willi syndrome, to map sensory processing patterns, to look for links between autistic/sensory features and behavior or eating problems, to assess family burden and quality of life, and to explore differences related to age, genetic subtype, and prior early oxytocin treatment.

What the researchers hope to learn. Describe prevalence, age patterns, and genetic-subtype differences in autistic symptomatology in PWS; characterize sensory processing profiles; correlate autistic and sensory findings with cognitive, behavioral, and eating‑related measures; evaluate impact on family burden and quality of life; explore associations with early oxytocin treatment history.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Prader-Willi Syndrome (PWS) is a rare neurodevelopmental disorder stemming from genetic damage in the 15q11-q13 region, leading to hypothalamic dysfunction. Individuals with PWS often exhibit social interaction challenges, intellectual deficits, significant eating disorders, mood disturbances, and sensory-related autistic features. Although PWS is recognized by DSM-5 as a genetic cause of Autism Spectrum Disorder (ASD), ASD diagnosis in PWS remains rare in France. The CASSPER study aims to investigate the distinct autistic and sensory profiles in children with PWS, also analyzing the potential impact of early oxytocin treatment on these manifestations, in line with recommendations for early and tailored intervention.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • psychological and sensorial tests

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Child with genetically confirmed PWS and identification of genetic subtype;
  • Child aged between 3 and 16 years;
  • Hospitalisation or multidisciplinary consultation planned for the child's routine follow-up at one of the investigating centres;
  • No parental/legal guardian objection.

Exclusion criteria

  • Change in psychotropic treatment (start, change in dose or discontinuation) in the past 3 months;
  • Inability to provide clear information to parents/legal guardian;
  • Not covered by social security.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Prader-Willi syndrome (PWS) is a rare and complex neurodevelopmental disorder (NDD) with genetic origin linked to chromosomal damage in the 15q11-q13 region and characterised by hypothalamic dysfunction. At the psychiatric level, patients with PWS display difficulties in social interaction, mild to moderate intellectual deficit, major eating disorders, mood disorders and autistic manifestations, including hypo-/hyper-reactivity to sensory stimuli. While the International Classification (DSM-5) lists PWS as one of the genetic causes of Autism Spectrum Disorder (ASD), little is known about the interaction between autistic traits, sensory features and PWS. To date, assessment and diagnosis of ASD in PWS remains exceptional in standard care in France, despite the obvious importance of correct assessment for early identification and intervention. In this context, the CASSPER study aims to identify the specificity of PWS in terms of autistic symptomatology and sensory characteristics. The CASSPER study is in line with the recommendations of the French National Health Authority (HAS) for early and appropriate guidance of children with PWS. In addition, almost all children with PWS under the age of 5 have received early treatment with oxytocin (OT). As the neuromodulatory effect of OT treatment and the involvement of this neurohormone in the development of attachment, social interaction and sensory processing may explain a difference in autistic symptomatology, this parameter will be included in the analyses. The CASSPER study aims to fill gaps in our knowledge of PWS and its care and could be useful more generally to improve our understanding of autistic manifestations in NDD of genetic origin.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Assessments take place during a planned routine hospital visit, over one to three days. The child will complete psychological and sensory tests (for example ADOS‑2 and ADI‑R for autistic symptoms, sensory questionnaires and an odor-identification test), may have an IQ or cognitive/behavioral evaluation, and parents will fill questionnaires about eating behavior and family impact. The study team will record medical history, including whether the child received early oxytocin treatment. The registry describes questionnaires and non‑invasive sensory tests; no invasive procedures are specified in the record.

How the study is structured. Observational, cross‑sectional case-only study. No experimental treatments are given. Children visit for assessments (completed within up to three days) including standardized autism interviews/tests, sensory assessments, cognitive and behavioral measures, and parent questionnaires. The study compares results across age groups, genetic subtypes, and prior early oxytocin exposure when that information is available.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Prader-Willi syndrome

Clinical trials19 trials listed for Prader-Willi syndromeEvery trial the registry lists for Prader-Willi syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Prader-Willi syndrome researchLatest monthly update: September 2026. Includes: Hunger symptoms. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Apr 7, 2025
Primary completion
Oct 30, 2026 (estimated)
Study completion
Oct 30, 2026 (estimated)
Target enrollment
75 participants (estimated)
Last updated on registry
May 8, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University Hospital, Toulouse

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
legal guardian
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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