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

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ClinicalTrials.gov Identifier: NCT05996497

Recruitment Status : Recruiting

First Posted : August 18, 2023

Last Update Posted : November 13, 2023

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Sponsor:

Collaborator:

Institut de l'Audition

Information provided by (Responsible Party):

Institut Pasteur

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.

Condition or disease	Intervention/treatment	Phase
Dyslexia	Behavioral: behavioral measures Other: Electrophysiological measures Other: Training 1 Other: Training 2	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	160 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Basic Science
Official Title:	Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years
Actual Study Start Date :	October 5, 2023
Estimated Primary Completion Date :	January 1, 2025
Estimated Study Completion Date :	July 1, 2025

Arms and Interventions

Arm	Intervention/treatment
Auditory Rhythmic at 30 Hz then GraphoGame Training 1 with Auditory Rhythmic at 30 Hz (6 weeks) then Training 2 with GraphoGame (6 weeks)	Behavioral: behavioral measures behavioral measures Other: Electrophysiological measures Electrophysiological measures Other: Training 1 Training 1 Other: Training 2 Training 2
GraphoGame then Rhythmic Auditory at 30 Hz Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at 30 Hz (6 weeks)	Behavioral: behavioral measures behavioral measures Other: Electrophysiological measures Electrophysiological measures Other: Training 1 Training 1 Other: Training 2 Training 2
Auditory Rhythmic at low frequencies then GraphoGame Training 1 with Auditory Rhythmic at low frequencies (6 weeks) then Training 2 with GraphoGame (6 weeks)	Behavioral: behavioral measures behavioral measures Other: Electrophysiological measures Electrophysiological measures Other: Training 1 Training 1 Other: Training 2 Training 2
GraphoGame then Auditory Low Frequency Rhythmic Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at Low Frequency Rhythmic (6 weeks)	Behavioral: behavioral measures behavioral measures Other: Electrophysiological measures Electrophysiological measures Other: Training 1 Training 1 Other: Training 2 Training 2

Outcome Measures

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). [ Time Frame: 2 years ]
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). [ Time Frame: 2 years ]
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. [ Time Frame: 2 years ]
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. [ Time Frame: 2 years ]
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

Eligibility Criteria

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Ages Eligible for Study:	7 Years to 9 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05996497

Contacts

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Contact: Sophie Bouton, PhD		sophie.bouton@pasteur.fr
Contact: Anne-Lise Giraud, PhD	+33176535054	anne-lise.giraud-mamessier@pasteur.fr

Locations

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France
Institut de l'Audition	Recruiting
Paris, France
Contact: Diane Lazard, MD

Sponsors and Collaborators

Institut Pasteur

Institut de l'Audition

Investigators

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Principal Investigator:	Diane Lazard, MD	Institut Pasteur
Study Director:	Anne-Lise Giraud, PhD	Institut Pasteur

More Information

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Responsible Party:	Institut Pasteur
ClinicalTrials.gov Identifier:	NCT05996497
Other Study ID Numbers:	2022-063 2022-A01132-41 ( Other Identifier: ID RCB )
First Posted:	August 18, 2023 Key Record Dates
Last Update Posted:	November 13, 2023
Last Verified:	August 2023

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Dyslexia Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations	Nervous System Diseases Specific Learning Disorder Learning Disabilities Neurodevelopmental Disorders Mental Disorders

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