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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslexia
• Intervention / Treatment: Device: Scintilling lamp; Device: Classic lamp

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Dr Laurence Derieux
  • Faumont, France, 59310
    • Dr Luc-Marie Virlet
  • Paris, France, 75935
    • Dr Hugo Peyre
  • Rennes, France, 35000
    • Dr Catherine ALLAIRE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scintilling lamp- Classic lamp	Device: Scintilling lamp; Lamp with a standardized scintilling; Device: Classic lamp; Lamp without a scintilling
Experimental: Classic lamp- Scintilling lamp	Device: Scintilling lamp; Lamp with a standardized scintilling; Device: Classic lamp; Lamp without a scintilling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reading performance aloud of a text with french E.L.FE Test	E.L.FE Test (=Evaluation de la Lecture en FluencE) - "Monsieur Petit" and "Le Géant égoïste" texts : percentile	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reading performance aloud of isolated words with french BALE Test	BALE test (=Batterie Analytique de Langage Ecrit): percentile	1 day
Security: incidence of Adverse Events	By questioning the patient & the speech therapist - evaluation of adverse effects due to scintilling lamp (Yes/ No): headache, nausea, dizziness, fatigue and eye fatigue. Accotding to patient questioning and clinical exam, the Adverse Event Table will be completed (description, dates, severity, imputability, action,...).	1 day
Patient's satisfaction regarding reading fluency	patient interview with VAS (Visual Analogue Scale): 0 - 100 mm	1 day
Speech therapist's satisfaction regarding Securirty, Performance and usability of scintilling lamp	speech therapist interview with 4 points - Likert scale (Very good, Good, Moderate, Bad)	1 day

Collaborators and Investigators

• Sponsor: SATT Ouest Valorisation
• Collaborators: Slb Pharma
• Investigators: Principal Investigator: Catherine Allaire, Dr, CHU Rennes

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Actual): January 8, 2021
• Study Completion (Actual): January 8, 2021

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Dyslexia; Reading disorder
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• Other Study ID Numbers: DysLight

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No