Specific Learning DisabilityDYSOMNCT06878690
Sleep Disorders in Specific Learning Disabilities
An observational study of Specific Learning Disability and Sleep, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Specific Learning Disability, Sleep, Sleep Disorder (Disorder)
- What is being tested?
- Online Questionnaire
- How many people
- 1,146 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2025to 16 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 1000 participants, 500 children and 500 adults. All with at least one diagnosed specific learning disability
Who may be able to join
- Children, adolescents and adults with a specific learning disability (dyslexia, dysorthography, dyscalculia, dysgraphia, dyspraxia, dysphasia).
- ≥ 4 ans
Who cannot join
- Participant opposing or whose parents oppose participation of this children in the protocol.
- Patients under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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:
- 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
- Conditions
- Specific Learning Disability, Sleep, Sleep Disorder (Disorder), ADHD
- Being tested
- Online Questionnaire
- Keywords
- Specific learning disabilities, Sleep, ADHD, Paediatric
- Medical subject headings
- Sleep Wake Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online QuestionnaireOther
Completion of an online questionnaire via the secure RedCap platform
| Study group | Role | What they receive |
|---|---|---|
| Children | Children (4 < 18 years old) with specific learning disabilities, associated or not with others medical condition Receives: Other: Online Questionnaire | |
| Adult | Adult (> 18 years old) with specific learning disabilities, associated or not with others medical condition Receives: Other: Online Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start16 Apr 2025
- Primary completion16 Apr 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific Learning DisabilityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878690
- Sponsor's protocol ID
- 69HCL24_0276
- Other IDs
- 2024-A01674-43
- Acronym
- DYSOM
- Status last verified
- May 2026
- First submitted
- 5 Mar 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Sleep Disorders in Patients With Specific Learning Disabilities According to Age, Sex, Associated Comorbidities and Treatments
- ClinicalTrials.gov ID
- NCT06878690
- Acronym / sponsor ID
- DYSOM / 69HCL24_0276
- Conditions
- Specific Learning Disability, Sleep, Sleep Disorder (Disorder), ADHD
- Keywords
- Specific learning disabilities, Sleep, ADHD, Paediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,146 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | Other: Online QuestionnaireChildren (4 < 18 years old) with specific learning disabilities, associated or not with others medical condition |
| Adult | – | Other: Online QuestionnaireAdult (> 18 years old) with specific learning disabilities, associated or not with others medical condition |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1000 participants, 500 children and 500 adults. All with at least one diagnosed specific learning disability
Key inclusion criteria (2 listed)
- Children, adolescents and adults with a specific learning disability (dyslexia, dysorthography, dyscalculia, dysgraphia, dyspraxia, dysphasia).
- ≥ 4 ans
Key exclusion criteria (2 listed)
- Participant opposing or whose parents oppose participation of this children in the protocol.
- Patients under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online QuestionnaireCompletion of an online questionnaire via the secure RedCap platform | Other | Adult, Children |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Specific Learning Disability and Sleep, run by Hospices Civils de Lyon at 1 site in France.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 14 May 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characterization of sleep disorders assessed using the Sleep Disturbances Scale for Children (SDSC) questionnaires in children (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.