Clinical trial NCT06878690: Sleep Disorders in Specific Learning Disabilities
Official title: Characterization of Sleep Disorders in Patients With Specific Learning Disabilities According to Age, Sex, Associated Comorbidities and Treatments
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Specific Learning Disability
Sleep
Sleep Disorder (Disorder)
ADHD
Keywords: Specific learning disabilities
Sleep
ADHD
Paediatric
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 participants, 500 children and 500 adults. All with at least one diagnosed specific learning disability

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Characterization of sleep disorders assessed using the Sleep Disturbances Scale for Children (SDSC) questionnaires in children
timeFrame: Baseline
measure: Characterization of sleep disorders assessed using the Pittsburg Sleep Quality Index score in adults
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
References: