NCT06947512

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2024

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2.7 years

First QC Date

March 20, 2024

Last Update Submit

April 30, 2025

Conditions

Keywords

Developmental DyslexiaReading DifficultiesPersonalizationVisual parametersAuditory parametersFontsText-to-Speech (TTS)

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    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

    about 10 months

  • possibility to discriminate TD students's reading accuracy from that of students with DD and SEN

    about 10 months

  • possibility to discriminate TD students' writing accuracy from that of students with DD and SEN

    about 10 months

  • validity and reliability values for the reading speed measures collected by the software

    about 10 months

  • validity and reliability values for the reading accuracy measures collected by the software

    about 10 months

  • +1 more secondary outcomes

Study Arms (1)

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

Device: Seleggo Test

Interventions

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.

Participant

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age 7-15 years
  • no history of reading difficulties
  • attends school in Italy

You may not qualify if:

  • special educational needs or diagnosis of neurodevelopmental disorders
  • age 7-15 years
  • diagnosis of Developmental Dyslexia or Specific Reading Disorder
  • Attends school in Italy
  • diagnosis of Intellectual Disability
  • 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)
  • diagnosis of Intellectual Disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IRCCS E. Medea, polo di Bosisio Parini

Bosisio Parini, LC, 23842, Italy

RECRUITING

IRCCS E.Medea, polo di Conegliano

Conegliano, TV, 31015, Italy

RECRUITING

Associazione La Nostra Famiglia

Treviso, TV, 31100, Italy

RECRUITING

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Maria Luisa Lorusso, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2024

First Posted

April 27, 2025

Study Start

February 16, 2023

Primary Completion

November 1, 2025

Study Completion

December 31, 2025

Last Updated

May 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Anonymous data will be shared through the Zenodo platform

Time Frame
From the publication of the results onwards
Access Criteria
free access, for anonymous data only

Locations