Evaluation of the Performance and Safety of a Medical Device Developed to Improve the Reading of Dyslexic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-18

Study Completion Date

2021-01-08

Brief Summary

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The aim of this study is to evaluate the efficacy and safety of a new medical device on the improvement of reading skills of dyslexic patients.

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Detailed Description

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Dyslexia is defined as a specific learning disability that is characterized by reading difficulties, in the absence of intellectual disability, neurological or psychiatric disorder, uncorrected sensory disturbance (sight, hearing) or an educational deficiency.

Dyslexia appears in the child from the earliest stages of learning in the form of a difficulty in mastering the learning of reading. This disorder is manifested by a generally hesitant reading, slowed down, full of errors, requiring a lot of effort for the child and may impact his reading comprehension. The dyslexia-related deficiency is of variable intensity depending on the individual; it may be accompanied by calculus disorders (dyscalculia), oral language (dysphasia), motor coordination (dyspraxia) or attention disorders with or without hyperactivity. In nearly 40% of cases, a child affected by Dys disorders presents several learning disorders.

To date, the causes of dyslexia are not yet clearly established. The wide variety of symptoms and disorders associated with dyslexia does not facilitate the identification of precise neurobiological / psycho cognitive mechanisms. There are therefore several theories: phonological, visual, temporal, cerebellar or proprioceptive auditory processing.

Recently, following work published in 2017, an anatomical cause based on Maxwell's spots could also be a cause of dyslexia.

The aim of this study is to evaluate a new medical device to compensate this probable anatomical cause.

Conditions

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Dyslexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Scintilling lamp- Classic lamp

Group Type EXPERIMENTAL

Scintilling lamp

Intervention Type DEVICE

Lamp with a standardized scintilling

Classic lamp

Intervention Type DEVICE

Lamp without a scintilling

Classic lamp- Scintilling lamp

Group Type EXPERIMENTAL

Scintilling lamp

Intervention Type DEVICE

Lamp with a standardized scintilling

Classic lamp

Intervention Type DEVICE

Lamp without a scintilling

Interventions

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Scintilling lamp

Lamp with a standardized scintilling

Intervention Type DEVICE

Classic lamp

Lamp without a scintilling

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Schooled in CE2, CM1 or CM2,
* French mother tongue,
* For whom developmental dyslexia has been diagnosed by a health professional who specializes in this learning disorder,
* Presenting an IQ ≥ 80 and ≤130 according to the WISC-V test performed by a psychologist,
* For which a written consent was obtained regarding his study participation.

Exclusion Criteria

* With medical history or presenting a neurological pathology,
* Presenting a developmental disorder (autism, ADHD, ...),
* Presenting hearing disorders,
* Presenting visual disorders,
* Any other condition that, in the opinion of health professionals, could impair its ability to complete the study or could pose a significant risk.

Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No