NCT04157829

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

Evaluation of the Performance and Safety of a Scintillating Lamp Developed to Improve the Reading of Dyslexic Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: SATT Ouest Valorisation · Academic / Other
• Sex: All
• Age: 8 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Dyslexia

Interventions

Type	Name	Description
DEVICE	Scintilling lamp	Lamp with a standardized scintilling
DEVICE	Classic lamp	Lamp without a scintilling

Timeline

• Start date: 2019-12-18
• Primary completion: 2021-01-08
• Completion: 2021-01-08
• First posted: 2019-11-08
• Last updated: 2021-04-29

Locations

4 sites across 1 country: France