NCT06878690

Brief Summary

Specific learning disorders, or SLD, are cognitive and behavioral conditions that emerge during childhood and involve significant difficulties in acquiring and performing specific intellectual, motor, language, and social functions. These disorders impact personal, social, academic, and professional functioning throughout life. In France, between 6% and 8% of the population, including both children and adults, are affected by at least one type of SLD. SLD are also frequently associated with Attention Deficit Hyperactivity Disorder (ADHD), with prevalence rates ranging from 33% to 70%, depending on the study. This comorbidity leads to more severe attention and learning difficulties than when ADHD or SLD occur independently. ADHD is a common neurodevelopmental disorder that affects cognitive attentional processes, with or without hyperactivity. It is estimated to affect approximately 5.3% of children and adolescents worldwide and about 3% of adults. The assessment of these disorders is conducted through a neuropsychological evaluation, which determines the type and severity of cognitive impairments. Several studies report that 55% to 74% of children with ADHD experience sleep difficulties. To date, only two studies have examined the prevalence of sleep disorders among children with SLD disorders. One of these studies focused exclusively on dyslexia, with or without ADHD. The results revealed significantly higher scores among dyslexic children compared to controls when completing sleep disorder assessment questionnaires (SDSC). The main difficulties were related to "sleep onset and maintenance disorders," "sleep-related breathing disorders," and "wakefulness disorders." The second study, using the same questionnaire, compared children with ADHD, SLD disorders, and both combined. The group with co-existing SLD and ADHD disorders exhibited significantly more sleep disturbances than the other groups, primarily sleep onset and maintenance disorders. Despite the importance of these studies, they focused only on sleep disorders associated with dyslexia, without considering other learning disorders such as dyspraxia, dyscalculia, or dysgraphia. Furthermore, when ADHD was taken into account, the studies did not differentiate between its various forms, limiting the interpretation of the results. Additionally, no research has tracked the evolution of sleep disorders in the SLD +/- ADHD population from childhood through adolescence and into adulthood. In this study, the investigators aim to evaluate sleep disorders in the SLD population (with or without ADHD) in France through online questionnaires. These questionnaires will be offered to 1,000 children (aged ≥4 years) and adults diagnosed with at least one specific learning disorder. Primary Objective: The main objective of this study is to assess the frequency and nature of sleep disorders in patients (both adults and children) with specific learning disorders, with or without ADHD. Secondary Objectives:

  • Characterize the "SLD" patient population in France by considering age and gender: o Determine the prevalence of co-morbidities, such as: ADHD Anxiety and depressive disorders Other reported medical conditions
  • Assess the types of care provided (medication or other) for both children and adults
  • Determine the frequency of SLD in a familial context
  • Identify whether the following factors are associated with a higher frequency of sleep disorders:
  • Single SLD vs. multiple SLD
  • The presence of ADHD, anxiety-depressive disorders, or other medical conditions alongside SLD
  • Demographic characteristics (age, gender, etc.)
  • Family history of SLD among relatives (parents and siblings)
  • Medication use

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 16, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

March 5, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

Specific learning disabilitiesSleepADHDPaediatric

Outcome Measures

Primary Outcomes (2)

  • Characterization of sleep disorders assessed using the Sleep Disturbances Scale for Children (SDSC) questionnaires in children

    Scores are obtained after completing the different subsections of the questionnaire. The subsections represent the different sleep disorders. The scores obtained in the different subsections define whether a disorder is present or not.

    Baseline

  • Characterization of sleep disorders assessed using the Pittsburg Sleep Quality Index score in adults

    Scores are obtained after completing the different subsections of the questionnaire. The subsections represent the different sleep disorders. The scores obtained in the different subsections define whether a disorder is present or not.

    Baseline

Study Arms (2)

Children

Children (4 \< 18 years old) with specific learning disabilities, associated or not with others medical condition

Other: Online Questionnaire

Adult

Adult (\> 18 years old) with specific learning disabilities, associated or not with others medical condition

Other: Online Questionnaire

Interventions

Completion of an online questionnaire via the secure RedCap platform

AdultChildren

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1000 participants, 500 children and 500 adults. All with at least one diagnosed specific learning disability

You may qualify if:

  • Children, adolescents and adults with a specific learning disability (dyslexia, dysorthography, dyscalculia, dysgraphia, dyspraxia, dysphasia).
  • ≥ 4 ans

You may not qualify if:

  • Participant opposing or whose parents oppose participation of this children in the protocol.
  • Patients under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Sleep Wake DisordersAttention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 17, 2025

Study Start

April 16, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 22, 2025

Record last verified: 2025-04

Locations