Evaluation of the Performance and Safety of a Medical Device Developed to Improve the Reading of Dyslexic Patients
DysLight
1 other identifier
interventional
33
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2019
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 8, 2019
CompletedStudy Start
First participant enrolled
December 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2021
CompletedApril 29, 2021
April 1, 2021
1.1 years
November 4, 2019
April 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Reading performance aloud of isolated words with french BALE Test
1 day
Security: incidence of Adverse Events
1 day
Patient's satisfaction regarding reading fluency
1 day
Speech therapist's satisfaction regarding Securirty, Performance and usability of scintilling lamp
1 day
Study Arms (2)
Scintilling lamp- Classic lamp
EXPERIMENTALClassic lamp- Scintilling lamp
EXPERIMENTALInterventions
Lamp with a standardized scintilling
Lamp without a scintilling
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SATT Ouest Valorisationlead
- Slb Pharmacollaborator
Study Sites (4)
Dr Laurence Derieux
Caen, 14000, France
Dr Luc-Marie Virlet
Faumont, 59310, France
Dr Hugo Peyre
Paris, 75935, France
Dr Catherine ALLAIRE
Rennes, 35000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Allaire, Dr
CHU Rennes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2019
First Posted
November 8, 2019
Study Start
December 18, 2019
Primary Completion
January 8, 2021
Study Completion
January 8, 2021
Last Updated
April 29, 2021
Record last verified: 2021-04