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Completed

NCT Number: NCT06596980

Examining the Effect of a Digital Medical Device for Cognitive and Musical Training in Children With Reading Disabilities

The goal of this clinical trial is to assess the effect on reading skills of the digital medical device Poppins Clinical for cognitive and musical training in pediatric participants (ages 7-11) with a specific learning disability with reading deficit. The main objective of the study is to assess the evolution in reading skills through a word reading task before and after the intervention.

Participants will be asked to train with the digital medical device Poppins Clinical 5 times per week for 8 weeks.

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Key information

Conditions

Learning Disorders, Specific Communication Disorders Dyslexia Language Disorders Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Specific Learning Disorder Specific Learning Disorder, With Impairment in Reading

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of SLD with reading deficit, based on a speech-language assessment. SLD with reading deficit is defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR, 2022) and the International Classification of Diseases (ICD-11, 2022). The speech-language assessment should consist of at least three reading and/or transcription tests with a SD (standard deviation) of at least - 1.4 or a result below the 20th percentile or two reading and/or transcription tests with a SD of at least - 2 SD or a results below the 10th percentile;
  • Subject aged between 7 and 11, enrolled from CE1 to CM2;
  • French mother tongue or French bilingualism at home and more than 3 years schooling in France;
  • Tablet or smartphone available at home;
  • Subject affiliated to the French National Insurance (Securite Sociale)
  • Subject and parental/legal guardians consent to participate, and commitment to follow the protocol.

Exclusion criteria

  • Subject has previously used Poppins Clinical or Mila-Learn;
  • Uncontrolled chronic illness (at investigator's discretion);
  • Previous epileptic seizures;
  • Participant actively participating in an interventional study that may affect results.

Treatment and study plan

Poppins Clinical

Device

Poppins Clinical is a software as a medical device that combines a musical and cognitive training program and written language training program.

Primary outcomes

  1. Effect of Poppins Clinical on reading abilities (accuracy)

    Time frame: 8 weeks

    Evaluate the effect of 8 weeks of training with Poppins Clinical on reading abilities (in terms of reading accuracy) of participants using a word reading task and measuring the number of correctly read words.

Secondary outcomes

  1. Reported adverse events

    Time frame: 8 weeks

    To evaluate safety, reported adverse events during the 8 weeks follow-up phase will be evaluated.

  2. Effect of Poppins Clinical on reading abilities (speed)

    Time frame: 8 weeks

    Evaluate the effect of 8 weeks of training with Poppins Clinical on reading abilities (in terms of speed) of participants using a word reading task and measuring the number of read words.

  3. Effect of Poppins Clinical on phonological skills

    Time frame: 8 weeks

    Evaluate the effect of 8 weeks of training with Poppins Clinical on phonological skills of participants using the BALE test.

  4. Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (accuracy)

    Time frame: 8 weeks

    Compare the effect of Poppins Clinical to the effect of the former version of the medical device (Mila-Learn) on reading abilities (in terms of reading accuracy) using a word reading task and measuring the number of correctly read words.

  5. Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (speed)

    Time frame: 8 weeks

    Compare the effect of Poppins Clinical to the effect of the former version of the medical device (Mila-Learn) on reading abilities (in terms of reading speed) using a word reading task and measuring the number of read words.

Sponsors and collaborators

Lead sponsor

Poppins

Industry

Registry information

Official study title

Single Arm Study Assessing the Effect of the Digital Medical Device Poppins Clinical for Cognitive and Musical Training in Pediatric Participants With a Specific Learning Disability With Deficits in Reading

Acronym: POPPINS-CE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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