Examining the Effect of a Digital Medical Device for Cognitive and Musical Training in Children With Reading Disabilities (POPPINS-CE)

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslexia; Learning Disabilities; Specific Learning Disorder, With Impairment in Reading; Learning Disorders, Specific
• Intervention / Treatment: Device: Poppins Clinical

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Hôpital Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm; Use of the medical device Poppins Clinical 5 times per weeks (20 minutes training sessions)	Device: Poppins Clinical; Poppins Clinical is a software as a medical device that combines a musical and cognitive training program and written language training program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reported adverse events	To evaluate safety, reported adverse events during the 8 weeks follow-up phase will be evaluated.	8 weeks
Effect of Poppins Clinical on reading abilities (speed)	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.	8 weeks
Effect of Poppins Clinical on phonological skills	Evaluate the effect of 8 weeks of training with Poppins Clinical on phonological skills of participants using the BALE test.	8 weeks
Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (accuracy)	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.	8 weeks
Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (speed)	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.	8 weeks

Collaborators and Investigators

• Sponsor: Poppins
• Investigators: Principal Investigator: David Cohen, Hôpital Pitié-Salpêtrière, Paris, France

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2024
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): February 11, 2025

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Language Disorders; Specific Learning Disorder; Learning Disabilities; Dyslexia
• Other Study ID Numbers: POPPINS-CE; 2024-A00432-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No