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

NCT06596980 | Completed

• 2 other identifiers: POPPINS-CE2024-A00432-45
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Learning Disorders, Specific; Learning Disabilities; Specific Learning Disorder, With Impairment in Reading; Dyslexia

Outcome Measures

Primary Outcomes (1)

• Effect of Poppins Clinical on reading abilities (accuracy)

  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.

  8 weeks

Secondary Outcomes (5)

• Reported adverse events

  8 weeks

• Effect of Poppins Clinical on reading abilities (speed)

  8 weeks

• Effect of Poppins Clinical on phonological skills

  8 weeks

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

  8 weeks

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

  8 weeks

Study Arms (1)

Interventional arm

EXPERIMENTAL

Use of the medical device Poppins Clinical 5 times per weeks (20 minutes training sessions)

Device: Poppins Clinical

Interventions

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.

Interventional arm

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poppins: lead

Study Sites (1)

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

• Grossard C, Descamps M, Pellerin H, Vonthron F, Cohen D. Children's Improvement After Language and Rhythm Training With the Digital Medical Device Poppins for Dyslexia: Single-Arm Intervention Study. JMIR Serious Games. 2025 Aug 1;13:e76435. doi: 10.2196/76435.

  PMID: 40750096 DERIVED

MeSH Terms

Conditions

Specific Learning Disorder; Learning Disabilities; Dyslexia

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Language Disorders

Study Officials

• David Cohen

  Hôpital Pitié-Salpêtrière, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: June 28, 2024
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)