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

Sponsor
Institut Pasteur (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05996497
Collaborator
Institut de l'Audition (Other)
160
1
4
21.5
7.4

Study Details

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
  • Behavioral: behavioral measures
  • Other: Electrophysiological measures
  • Other: Training 1
  • Other: Training 2
N/A

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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Other: 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

Other: 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

Other: 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

  1. 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). [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.

  2. 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). [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

  1. Measurement of reading accuracy (percentage of correct responses in the isolated pseudoword reading task) between multiple conditions. [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

  2. Measurement of reading speed (reading time in the isolated pseudoword reading task) between multiple conditions. [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

Criteria

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

Locations

Site City State Country Postal Code
1 Institut de l'Audition Paris France

Sponsors and Collaborators

  • Institut Pasteur
  • Institut de l'Audition

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Pasteur
ClinicalTrials.gov Identifier:
NCT05996497
Other Study ID Numbers:
  • 2022-063
  • 2022-A01132-41
First Posted:
Aug 18, 2023
Last Update Posted:
Aug 18, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2023