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

NCT ID: NCT05996497

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-05

Study Completion Date

2026-07-01

Brief Summary

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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

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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.

Conditions

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Dyslexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Auditory Rhythmic at 30 Hz then GraphoGame

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

Group Type OTHER

behavioral measures

Intervention Type BEHAVIORAL

behavioral measures

Electrophysiological measures

Intervention Type OTHER

Electrophysiological measures

Training 1

Intervention Type OTHER

Training 1

Training 2

Intervention Type OTHER

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)

Group Type OTHER

behavioral measures

Intervention Type BEHAVIORAL

behavioral measures

Electrophysiological measures

Intervention Type OTHER

Electrophysiological measures

Training 1

Intervention Type OTHER

Training 1

Training 2

Intervention Type OTHER

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)

Group Type OTHER

behavioral measures

Intervention Type BEHAVIORAL

behavioral measures

Electrophysiological measures

Intervention Type OTHER

Electrophysiological measures

Training 1

Intervention Type OTHER

Training 1

Training 2

Intervention Type OTHER

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)

Group Type OTHER

behavioral measures

Intervention Type BEHAVIORAL

behavioral measures

Electrophysiological measures

Intervention Type OTHER

Electrophysiological measures

Training 1

Intervention Type OTHER

Training 1

Training 2

Intervention Type OTHER

Training 2

Interventions

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behavioral measures

behavioral measures

Intervention Type BEHAVIORAL

Electrophysiological measures

Electrophysiological measures

Intervention Type OTHER

Training 1

Training 1

Intervention Type OTHER

Training 2

Training 2

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de l'Audition

OTHER

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diane Lazard, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur

Anne-Lise Giraud, PhD

Role: STUDY_DIRECTOR

Institut Pasteur

Locations

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Institut de l'Audition

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sophie Bouton, PhD

Role: CONTACT

Anne-Lise Giraud, PhD

Role: CONTACT

+33176535054

Facility Contacts

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Diane Lazard, MD

Role: primary

Other Identifiers

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2022-A01132-41

Identifier Type: OTHER

Identifier Source: secondary_id

2022-063

Identifier Type: -

Identifier Source: org_study_id

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