- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06878690
Sleep Disorders in Specific Learning Disabilities (DYSOM)
Characterization of Sleep Disorders in Patients With Specific Learning Disabilities According to Age, Sex, Associated Comorbidities and Treatments
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bron, France, 69500
- Hospices Civils de Lyon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children
Children (4 < 18 years old) with specific learning disabilities, associated or not with others medical condition
|
Completion of an online questionnaire via the secure RedCap platform
|
|
Adult
Adult (> 18 years old) with specific learning disabilities, associated or not with others medical condition
|
Completion of an online questionnaire via the secure RedCap platform
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characterization of sleep disorders assessed using the Sleep Disturbances Scale for Children (SDSC) questionnaires in children
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL24_0276
- 2024-A01674-43 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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