DyslexiaRnDysNCT05996497
Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years
A study testing behavioral measures, Electrophysiological measures and Training 1 in people with Dyslexia, run by Institut Pasteur at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Dyslexia
- What is being tested?
- behavioral measures, Electrophysiological measures and Training 1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2023to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- have any other diagnosis of language impairment
- have a neurological disorder (visual, auditory, executive)
- have an associated psychiatric disorder
- have a developmental delay.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sophie Bouton, PhD contact
France1 site, 1 recruiting
- Recruiting
Institut de l'Audition
Paris
Diane Lazard, MD
About this study
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.
Read the 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.
- Conditions
- Dyslexia
- Being tested
- behavioral measures, Electrophysiological measures, Training 1, Training 2
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral measuresBehavioural
behavioral measures
Electrophysiological measuresOther
Electrophysiological measures
Training 1Other
Training 1
Training 2Other
Training 2
| Study group | Role | What they receive |
|---|---|---|
| Auditory Rhythmic at 30 Hz then GraphoGame | Other | Training 1 with Auditory Rhythmic at 30 Hz (6 weeks) then Training 2 with GraphoGame (6 weeks) Receives: Behavioral: behavioral measures; Other: Electrophysiological measures; Other: Training 1; Other: Training 2 |
| GraphoGame then Rhythmic Auditory at 30 Hz | Other | Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at 30 Hz (6 weeks) Receives: Behavioral: behavioral measures; Other: Electrophysiological measures; Other: Training 1; Other: Training 2 |
| Auditory Rhythmic at low frequencies then GraphoGame | Other | Training 1 with Auditory Rhythmic at low frequencies (6 weeks) then Training 2 with GraphoGame (6 weeks) Receives: Behavioral: behavioral measures; Other: Electrophysiological measures; Other: Training 1; Other: Training 2 |
| GraphoGame then Auditory Low Frequency Rhythmic | Other | Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at Low Frequency Rhythmic (6 weeks) Receives: Behavioral: behavioral measures; Other: Electrophysiological measures; Other: Training 1; Other: Training 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 2 years
Secondary outcomes (2)
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
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start5 Oct 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut de l'Audition
- Responsible party
- Sponsor
- Investigators
- Diane Lazard, MD, Principal investigator, Institut PasteurAnne-Lise Giraud, PhD, Study director, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996497
- Sponsor's protocol ID
- 2022-063
- Other IDs
- 2022-A01132-41
- Acronym
- RnDys
- Status last verified
- Feb 2025
- First submitted
- 22 May 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years
- ClinicalTrials.gov ID
- NCT05996497
- Acronym / sponsor ID
- RnDys / 2022-063
- Conditions
- Dyslexia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut de l'Audition
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Auditory Rhythmic at 30 Hz then GraphoGame | Other | Behavioral: behavioral measures, Other: Electrophysiological measures, Other: Training 1, Other: Training 2Training 1 with Auditory Rhythmic at 30 Hz (6 weeks) then Training 2 with GraphoGame (6 weeks) |
| GraphoGame then Rhythmic Auditory at 30 Hz | Other | Behavioral: behavioral measures, Other: Electrophysiological measures, Other: Training 1, Other: Training 2Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at 30 Hz (6 weeks) |
| Auditory Rhythmic at low frequencies then GraphoGame | Other | Behavioral: behavioral measures, Other: Electrophysiological measures, Other: Training 1, Other: Training 2Training 1 with Auditory Rhythmic at low frequencies (6 weeks) then Training 2 with GraphoGame (6 weeks) |
| GraphoGame then Auditory Low Frequency Rhythmic | Other | Behavioral: behavioral measures, Other: Electrophysiological measures, Other: Training 1, Other: Training 2Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at Low Frequency Rhythmic (6 weeks) |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- have any other diagnosis of language impairment
- have a neurological disorder (visual, auditory, executive)
- have an associated psychiatric disorder
- have a developmental delay.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral measuresbehavioral measures | Behavioural | Auditory Rhythmic at 30 Hz then GraphoGame, Auditory Rhythmic at low frequencies then GraphoGame, GraphoGame then Auditory Low Frequency Rhythmic, GraphoGame then Rhythmic Auditory at 30 Hz |
| Electrophysiological measuresElectrophysiological measures | Other | Auditory Rhythmic at 30 Hz then GraphoGame, Auditory Rhythmic at low frequencies then GraphoGame, GraphoGame then Auditory Low Frequency Rhythmic, GraphoGame then Rhythmic Auditory at 30 Hz |
| Training 1Training 1 | Other | Auditory Rhythmic at 30 Hz then GraphoGame, Auditory Rhythmic at low frequencies then GraphoGame, GraphoGame then Auditory Low Frequency Rhythmic, GraphoGame then Rhythmic Auditory at 30 Hz |
| Training 2Training 2 | Other | Auditory Rhythmic at 30 Hz then GraphoGame, Auditory Rhythmic at low frequencies then GraphoGame, GraphoGame then Auditory Low Frequency Rhythmic, GraphoGame then Rhythmic Auditory at 30 Hz |
Primary outcome
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.
2 secondary outcomes
Measurement of reading accuracy (percentage of correct responses in the isolated pseudoword reading task) between multiple conditions.
Time frame: 2 years
Measurement of reading speed (reading time in the isolated pseudoword reading task) between multiple conditions.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie Bouton, PhD contact
Diane Lazard, MD principal investigator
Institut Pasteur
Anne-Lise Giraud, PhD study director
Institut Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral measures, Electrophysiological measures and Training 1 in people with Dyslexia, run by Institut Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Bouton, PhD (sophie.bouton@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.