search
Back to results

Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years (RnDys)

Primary Purpose

Dyslexia

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
behavioral measures
Electrophysiological measures
Training 1
Training 2
Sponsored by
Institut Pasteur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dyslexia

Eligibility Criteria

7 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: between 7 and 9 years old in regular schooling have a diagnosis of dyslexia have a non-verbal intelligence assessment within the norm. Inclusion assessments must show a major reading disability without associated cognitive deficits. be equipped with a PC at home have given their assent and whose parents/legal guardians have given their oral consent Exclusion Criteria: have any other diagnosis of language impairment have a neurological disorder (visual, auditory, executive) have an associated psychiatric disorder have a developmental delay.

Sites / Locations

  • Institut de l'Audition

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Auditory Rhythmic at 30 Hz then GraphoGame

GraphoGame then Rhythmic Auditory at 30 Hz

Auditory Rhythmic at low frequencies then GraphoGame

GraphoGame then Auditory Low Frequency Rhythmic

Arm Description

Training 1 with Auditory Rhythmic at 30 Hz (6 weeks) then Training 2 with GraphoGame (6 weeks)

Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at 30 Hz (6 weeks)

Training 1 with Auditory Rhythmic at low frequencies (6 weeks) then Training 2 with GraphoGame (6 weeks)

Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at Low Frequency Rhythmic (6 weeks)

Outcomes

Primary Outcome Measures

Comparison of reading accuracy by measuring the percentage of correct responses in the isolated pseudoword reading task between rythmic auditory training condition vs. grapho-phonological mapping training (GraphoGame).
Comparison of reading performance is assessed in terms of both accuracy and speed. High percentage of correct responses means that children improve their reading accuracy.
Comparison of reading speed by measuring reading time in the isolated pseudoword reading task between rythmic auditory training condition vs. grapho-phonological mapping training (GraphoGame).
Comparison of reading performance is assessed in terms of both accuracy and speed. A short time means that children improve their reading speed.

Secondary Outcome Measures

Measurement of reading accuracy (percentage of correct responses in the isolated pseudoword reading task) between multiple conditions.
Reading accuracy compared between rhythmic auditory training then grapho-phonological mapping training vs. grapho-phonological mapping training then rhythmic auditory training and rhythmic auditory training at 30 Hz vs. rhythmic auditory training at 3.5 Hz
Measurement of reading speed (reading time in the isolated pseudoword reading task) between multiple conditions.
Reading speed compared between rhythmic auditory training then grapho-phonological mapping training vs. grapho-phonological mapping training then rhythmic auditory training and rhythmic auditory training at 30 Hz vs. rhythmic auditory training at 3.5 Hz

Full Information

First Posted
May 22, 2023
Last Updated
August 9, 2023
Sponsor
Institut Pasteur
Collaborators
Institut de l'Audition
search

1. Study Identification

Unique Protocol Identification Number
NCT05996497
Brief Title
Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years
Acronym
RnDys
Official Title
Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur
Collaborators
Institut de l'Audition

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Studies of dyslexia have shown altered oscillatory activity in the low gamma band (~25-35 Hz) in the left auditory cortex. Neural oscillations around 30 Hz constitute the basic sampling rate of speech, from which the ability to form specific phonemic categories on which reading learning is based is derived. An alteration of the oscillatory activity at 30 Hz could therefore influence the ability of children to learn to read, and explain the reading deficit observed in children with a specific written language disorder. The objective of our study is to determine whether intensive rhythmic auditory stimulation applied during 30 sessions of 15 minutes spread over 6 weeks (5 sessions per week) can correct neural oscillations in the gamma-low band, allowing an improvement of phonemic categorization abilities, and thus the reading abilities of dyslexic readers aged 7 to 9 years. The long-term objective of this study is to test the therapeutic potential of auditory stimulation with speech rhythms for the treatment of reading disorders.
Detailed Description
Longitudinal cross-over study carried out on 4 experimental groups to compare the effect of two rhythmic auditory trainings (30 Hz and low frequencies) compared to the effect of a grapho-phonological correspondence training (GraphoGame). The study begins with a recruitment and inclusion period after diagnosis of dyslexia. During this study, 4 assessments are performed and include behavioral measures in the care setting and electrophysiological measures in the research setting: at time T1 before any remediation, at T2 after the first training, at T3 at most 7 days after the 2nd training session, at T4 seven weeks after T3. After the T1 assessment, participants were randomized into 4 different groups (training 1 then training 2): Group 1 : Auditory Rhythmic at 30 Hz then GraphoGame Group 2 : GraphoGame then Rhythmic Auditory at 30 Hz Group 3 : Auditory Rhythmic at low frequencies then GraphoGame Group 4 : GraphoGame then Auditory Low Frequency Rhythmic The first training period (total duration 6 weeks) according to the assigned group begins and takes place at the speech therapist's office and at home. After the T2 evaluation, the 2nd training period (total duration 6 weeks) according to the assigned group begins and takes place at the SLP's office as well as at home. The post-training evaluations T3 and T4 take place, respectively, 1 week and 7 weeks after the last training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auditory Rhythmic at 30 Hz then GraphoGame
Arm Type
Other
Arm Description
Training 1 with Auditory Rhythmic at 30 Hz (6 weeks) then Training 2 with GraphoGame (6 weeks)
Arm Title
GraphoGame then Rhythmic Auditory at 30 Hz
Arm Type
Other
Arm Description
Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at 30 Hz (6 weeks)
Arm Title
Auditory Rhythmic at low frequencies then GraphoGame
Arm Type
Other
Arm Description
Training 1 with Auditory Rhythmic at low frequencies (6 weeks) then Training 2 with GraphoGame (6 weeks)
Arm Title
GraphoGame then Auditory Low Frequency Rhythmic
Arm Type
Other
Arm Description
Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at Low Frequency Rhythmic (6 weeks)
Intervention Type
Behavioral
Intervention Name(s)
behavioral measures
Intervention Description
behavioral measures
Intervention Type
Other
Intervention Name(s)
Electrophysiological measures
Intervention Description
Electrophysiological measures
Intervention Type
Other
Intervention Name(s)
Training 1
Intervention Description
Training 1
Intervention Type
Other
Intervention Name(s)
Training 2
Intervention Description
Training 2
Primary Outcome Measure Information:
Title
Comparison of reading accuracy by measuring the percentage of correct responses in the isolated pseudoword reading task between rythmic auditory training condition vs. grapho-phonological mapping training (GraphoGame).
Description
Comparison of reading performance is assessed in terms of both accuracy and speed. High percentage of correct responses means that children improve their reading accuracy.
Time Frame
2 years
Title
Comparison of reading speed by measuring reading time in the isolated pseudoword reading task between rythmic auditory training condition vs. grapho-phonological mapping training (GraphoGame).
Description
Comparison of reading performance is assessed in terms of both accuracy and speed. A short time means that children improve their reading speed.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Measurement of reading accuracy (percentage of correct responses in the isolated pseudoword reading task) between multiple conditions.
Description
Reading accuracy compared between rhythmic auditory training then grapho-phonological mapping training vs. grapho-phonological mapping training then rhythmic auditory training and rhythmic auditory training at 30 Hz vs. rhythmic auditory training at 3.5 Hz
Time Frame
2 years
Title
Measurement of reading speed (reading time in the isolated pseudoword reading task) between multiple conditions.
Description
Reading speed compared between rhythmic auditory training then grapho-phonological mapping training vs. grapho-phonological mapping training then rhythmic auditory training and rhythmic auditory training at 30 Hz vs. rhythmic auditory training at 3.5 Hz
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: between 7 and 9 years old in regular schooling have a diagnosis of dyslexia have a non-verbal intelligence assessment within the norm. Inclusion assessments must show a major reading disability without associated cognitive deficits. be equipped with a PC at home have given their assent and whose parents/legal guardians have given their oral consent Exclusion Criteria: have any other diagnosis of language impairment have a neurological disorder (visual, auditory, executive) have an associated psychiatric disorder have a developmental delay.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Bouton, PhD
Email
sophie.bouton@pasteur.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Lise Giraud, PhD
Phone
+33176535054
Email
anne-lise.giraud-mamessier@pasteur.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane Lazard, MD
Organizational Affiliation
Institut Pasteur
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne-Lise Giraud, PhD
Organizational Affiliation
Institut Pasteur
Official's Role
Study Director
Facility Information:
Facility Name
Institut de l'Audition
City
Paris
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Lazard, MD

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years

We'll reach out to this number within 24 hrs