Developmental DyslexiaNCT06947512
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
A study testing Seleggo Test in people with Developmental Dyslexia and Reading Problem, run by IRCCS Eugenio Medea at 3 sites in Italy.
Trial summary
Previous research has shown the importance of font type, size and spacing to facilitate text reading in dyslexia. A special automatized procedure was designed to select the most favorable parameters for both text visualization and text-to-speech (TTS) conversion to be used by students with reading difficulties. Read more about this study
- Who is it for?
- Ages 7 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dyslexia, Reading Problem
- What is being tested?
- Seleggo Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesItaly
- Study dates
- 16 Feb 2023to 31 Dec 2025
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 7-15 years
- no history of reading difficulties
- attends school in Italy
- age 7-15 years
- diagnosis of Developmental Dyslexia or Specific Reading Disorder
- Attends school in Italy
Show all 9Show fewer
- age 7-15 years
- reported by school to have significant difficulties in reading and writing
- Attends school in Italy (at least 6 months continued schooling and exposure to the Italian language)
Who cannot join
- special educational needs or diagnosis of neurodevelopmental disorders
- diagnosis of Intellectual Disability
- diagnosis of Intellectual Disability
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
IRCCS E. Medea, polo di Bosisio Parini
Bosisio Parini, LC, 23842
Maria Luisa Lorusso, Ph.D, 031-877592, marialuisa.lorusso@lanostrafamiglia.it
Francesca Borasio, Ph.D, francesca.borasio@lanostrafamiglia.it
- Recruiting
IRCCS E.Medea, polo di Conegliano
Conegliano, TV, 31015
Federica Martinez, MD, federica.martinez@lanostrafamiglia.it
- Recruiting
Associazione La Nostra Famiglia
Treviso, TV, 31100
Malida Franzoi, MD, malida.franzoi@lanostrafamiglia.it
About this study
Official title: Efficacy of the Personalization of Visual Parameters and Text-to-Speech to Improve Reading Speed, Accuracy and Comprehension in Students With Learning Disorders
Previous research has shown the importance of font type, size and spacing to facilitate text reading in dyslexia. A special automatized procedure was designed to select the most favorable parameters for both text visualization and text-to-speech (TTS) conversion to be used by students with reading difficulties. The validation of its outcomes will be carried out through a systematic comparison of the use of the personalized versus standard fonts and voices in reading and writing tests.
Read the detailed description
Seleggo is a free compensatory tool for dyslexic students. It is an online platform where school textbooks are transcribed and visualized on the screen in portable format (PDF) versions, characterized by special attention to graphical features and readability, and can be listened to via TTS technology. Special functions such as karaoke modality, conceptual maps building software, summary creation, verbal and visual definition search and the possibility to record and retrieve one's own notes and sketches are also provided. Each student with Specific learning Disorder (SLD) has a personal library and can choose the parameters for text visualization to facilitate reading, modifying the display of the text, choosing font, size and spacing, as well as TTS parameters, such as speed and pitch.
The availability of many options for text visualization and TTS, however, can be advantageous only as far as the students are able to choose and use parameters that objectively facilitate their reading and comprehension. Since the analysis of the literature suggests that subjective choices may be misleading and that general recommendations may not fit the individual's needs, we decided to build an automatized, as objective as possible procedure to help the students find the combination of parameters that is most likely to facilitate them in reading and studying. This procedure, composed by an initial, gross-grained subjective procedure and followed by a thorough, systematic analysis of reading and comprehension performance, was named "Seleggo test" to match the compensatory tool it was meant to complement.
The present study aims to assess the actual advantage of personalized parameter selection through the "Seleggo Test" procedure in supporting reading compared to the use of standard parameters. The working hypothesis is that children with reading disorders would benefit from personalized text features and TTS.
The recruitment of participants will take place in schools. It is foreseen that 30 participants are recruited for each of the three groups: typically Developing children (TD), Developmental Dyslexia (DD) and Special Educational Needs (SEN) - with reading difficulties).
Additional children will be recruited form patients with DD at Scientific Institute (IRCCS) E. Medea, if necessary to reach the expected number. Children will attend the third grade of primary school to the third grade of middle school (7 to 15 years old).
- Conditions
- Developmental Dyslexia, Reading Problem
- Being tested
- Seleggo Test
- Keywords
- Developmental Dyslexia, Reading Difficulties, Personalization, Visual parameters, Auditory parameters, Fonts, Text-to-Speech (TTS)
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seleggo TestDevice
Seleggo Test is a computerized procedure to identify the personalized visual and auditory parameters facilitating reading and writing for each participant. By applying these parameters to the visualization and to the TTS software during reading of school texts, the participants are expected to be facilitated in reading and understanding the text.
| Study group | Role | What they receive |
|---|---|---|
| Participant | Experimental | All participants in the study will be assessed with the Seleggo Test procedure and then tested on reading and writing to dictation in the two conditions, with personalized and with standard visual and auditory parameters for text visualization and TTS Receives: Device: Seleggo Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading facilitation (speed), i.e. the advantage in reading performance (speed) produced by personalized parameters as compared to standard parameters
difference between reading speed (seconds to read the text displayed by the software) with personalized and with standard visual parameters
Measured: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
Reading facilitation (accuracy), i.e. the advantage in reading performance (accuracy) produced by personalized parameters as compared to standard parameters
difference between reading accuracy (number of errors in reading the text displayed by the software) with personalized and with standard visual parameters
Measured: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
Comprehension facilitation, i.e. the advantage in auditory comprehension performance produced by personalized TTS parameters as compared to standard parameters
difference between writing accuracy (number of errors in writing a pre-defined list of nonwords) for stimuli dictated with personalized and with standard auditory parameters in the TTS device
Measured: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
Secondary outcomes (6)
possibility to discriminate TD students' reading speed from that of students with DD and SEN
difference (ANOVAs) in performance (in terms of speed, expressed in seconds per syllable) on the reading tests delivered by the software, between the three groups (TD, DD and SEN)
Measured: about 10 months
possibility to discriminate TD students's reading accuracy from that of students with DD and SEN
difference (ANOVAs) in performance (in terms of accuracy, expressed in number of errors) on the reading tests delivered by the software, between the three groups (TD, DD and SEN)
Measured: about 10 months
possibility to discriminate TD students' writing accuracy from that of students with DD and SEN
difference (ANOVAs) in performance (in terms of accuracy, expressed in number of errors) on the writing tests delivered by the software, between the three groups (TD, DD and SEN)
Measured: about 10 months
validity and reliability values for the reading speed measures collected by the software
Pearson's correlations between the speed measures collected during the test and the speed measures obtained on standardized reading tests (MT test of reading speed and accuracy and Assessment Battery for Developmental Reading and Spelling Disorders).
Measured: about 10 months
validity and reliability values for the reading accuracy measures collected by the software
Pearson's correlations between the reading accuracy measures collected during the test and the accuracy measures obtained on standardized reading tests (MT test of reading speed and accuracy and Assessment Battery for Developmental Reading and Spelling Disorders).
Measured: about 10 months
validity and reliability values for the writing accuracy measures collected by the software
Pearson's correlations between the writing accuracy measures collected during the test and the accuracy measures obtained on standardized writing tests (Assessment Battery for Developmental Reading and Spelling Disorders).
Measured: about 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start16 Feb 2023
- Primary completionNov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental DyslexiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each of the participants will be tested in two conditions: with personalized parameters and with standard parameters. Their performance in reading and writing to dictation will be compared in a single-group, within-subjects model. A post-hoc comparison will also be conducted to confirm the validity of the procedure by assessing the existence of the predicted between-groups differences in reading and writing performance.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947512
- Sponsor's protocol ID
- 996
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous data will be shared through the Zenodo platform
Publications
Lorusso ML, Borasio F, Panetto P, Curioni M, Brotto G, Pons G, Carsetti A, Molteni M. Validation of a Web App Enabling Children with Dyslexia to Identify Personalized Visual and Auditory Parameters Facilitating Online Text Reading. Multimodal Technologies and Interaction. 2024; 8(1):5.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Personalization of Visual Parameters and Text-to-Speech to Improve Reading Speed, Accuracy and Comprehension in Students With Learning Disorders
- ClinicalTrials.gov ID
- NCT06947512
- Acronym / sponsor ID
- 996
- Conditions
- Developmental Dyslexia, Reading Problem
- Keywords
- Developmental Dyslexia, Reading Difficulties, Personalization, Visual parameters, Auditory parameters, Fonts, Text-to-Speech (TTS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Apr 2025 (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.
Previous research has shown the importance of font type, size and spacing to facilitate text reading in dyslexia. A special automatized procedure was designed to select the most favorable parameters for both text visualization and text-to-speech (TTS) conversion to be used by students with reading difficulties. The validation of its outcomes will be carried out through a systematic comparison of the use of the personalized versus standard fonts and voices in reading and writing tests.
Detailed description
Seleggo is a free compensatory tool for dyslexic students. It is an online platform where school textbooks are transcribed and visualized on the screen in portable format (PDF) versions, characterized by special attention to graphical features and readability, and can be listened to via TTS technology. Special functions such as karaoke modality, conceptual maps building software, summary creation, verbal and visual definition search and the possibility to record and retrieve one's own notes and sketches are also provided. Each student with Specific learning Disorder (SLD) has a personal library and can choose the parameters for text visualization to facilitate reading, modifying the display of the text, choosing font, size and spacing, as well as TTS parameters, such as speed and pitch.
The availability of many options for text visualization and TTS, however, can be advantageous only as far as the students are able to choose and use parameters that objectively facilitate their reading and comprehension. Since the analysis of the literature suggests that subjective choices may be misleading and that general recommendations may not fit the individual's needs, we decided to build an automatized, as objective as possible procedure to help the students find the combination of parameters that is most likely to facilitate them in reading and studying. This procedure, composed by an initial, gross-grained subjective procedure and followed by a thorough, systematic analysis of reading and comprehension performance, was named "Seleggo test" to match the compensatory tool it was meant to complement.
The present study aims to assess the actual advantage of personalized parameter selection through the "Seleggo Test" procedure in supporting reading compared to the use of standard parameters. The working hypothesis is that children with reading disorders would benefit from personalized text features and TTS.
The recruitment of participants will take place in schools. It is foreseen that 30 participants are recruited for each of the three groups: typically Developing children (TD), Developmental Dyslexia (DD) and Special Educational Needs (SEN) - with reading difficulties).
Additional children will be recruited form patients with DD at Scientific Institute (IRCCS) E. Medea, if necessary to reach the expected number. Children will attend the third grade of primary school to the third grade of middle school (7 to 15 years old).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each of the participants will be tested in two conditions: with personalized parameters and with standard parameters. Their performance in reading and writing to dictation will be compared in a single-group, within-subjects model. A post-hoc comparison will also be conducted to confirm the validity of the procedure by assessing the existence of the predicted between-groups differences in reading and writing performance.
| Arm | Type | Receives |
|---|---|---|
| Participant | Experimental | Device: Seleggo TestAll participants in the study will be assessed with the Seleggo Test procedure and then tested on reading and writing to dictation in the two conditions, with personalized and with standard visual and auditory parameters for text visualization and TTS |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- age 7-15 years
- no history of reading difficulties
- attends school in Italy
- age 7-15 years
- diagnosis of Developmental Dyslexia or Specific Reading Disorder
Key exclusion criteria (3 listed)
- special educational needs or diagnosis of neurodevelopmental disorders
- diagnosis of Intellectual Disability
- diagnosis of Intellectual Disability
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 |
|---|---|---|
| Seleggo TestSeleggo Test is a computerized procedure to identify the personalized visual and auditory parameters facilitating reading and writing for each participant. By applying these parameters to the visualization and to the TTS software during reading of school texts, the participants are expected to be facilitated in reading and understanding the text. | Device | Participant |
Primary outcome
Reading facilitation (speed), i.e. the advantage in reading performance (speed) produced by personalized parameters as compared to standard parameters
Time frame: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
difference between reading speed (seconds to read the text displayed by the software) with personalized and with standard visual parameters
Reading facilitation (accuracy), i.e. the advantage in reading performance (accuracy) produced by personalized parameters as compared to standard parameters
Time frame: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
difference between reading accuracy (number of errors in reading the text displayed by the software) with personalized and with standard visual parameters
Comprehension facilitation, i.e. the advantage in auditory comprehension performance produced by personalized TTS parameters as compared to standard parameters
Time frame: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)
difference between writing accuracy (number of errors in writing a pre-defined list of nonwords) for stimuli dictated with personalized and with standard auditory parameters in the TTS device
6 secondary outcomes
possibility to discriminate TD students' reading speed from that of students with DD and SEN
Time frame: about 10 months
possibility to discriminate TD students's reading accuracy from that of students with DD and SEN
Time frame: about 10 months
possibility to discriminate TD students' writing accuracy from that of students with DD and SEN
Time frame: about 10 months
validity and reliability values for the reading speed measures collected by the software
Time frame: about 10 months
validity and reliability values for the reading accuracy measures collected by the software
Time frame: about 10 months
validity and reliability values for the writing accuracy measures collected by the software
Time frame: about 10 months
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 4 May 2025.
- Results publicationLorusso ML, Borasio F, Panetto P, Curioni M, Brotto G, Pons G, Carsetti A, Molteni M. Validation of a Web App Enabling Children with Dyslexia to Identify Personalized Visual and Auditory Parameters Facilitating Online Text Reading. Multimodal Technologies and Interaction. 2024; 8(1):5.
- Individual participant dataSharing planned: Yes. Anonymous data will be shared through the Zenodo platform
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seleggo Test in people with Developmental Dyslexia and Reading Problem, run by IRCCS Eugenio Medea at 3 sites in Italy.
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 9 inclusion and 3 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 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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 Maria Luisa Lorusso, Ph.D (031-877592, marialuisa.lorusso@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading facilitation (speed), i.e. the advantage in reading performance (speed) produced by personalized parameters as compared to standard parameters (time frame: Intervention will take place during initial assessment and will last about 1,5 hours (comparison between personalized and standard parameters during the same assessment session)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06947512, which also lists 1 linked publication.
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 4 May 2025.