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

NCT06596980 — Not applicable, Completed, 38 participants, Poppins

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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

Registry	NCT06596980, acronym POPPINS-CE
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	38 (Actual)
Sponsor	Poppins (Industry)
Conditions	Learning Disorders, Specific, Learning Disabilities, Specific Learning Disorder, With Impairment in Reading, Dyslexia
Interventions	Poppins Clinical (Device)
Dates	start 2024-06-28, primary completion 2025-02-11, completion 2025-02-11, first posted 2024-09-19, last updated 2025-03-18
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Interventional arm	Experimental	Device: Poppins Clinical	Use of the medical device Poppins Clinical 5 times per weeks (20 minutes training sessions)

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.

+Outcome measures

Primary outcomes

Effect of Poppins Clinical on reading abilities (accuracy) [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

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

+Eligibility

Sex: All, ages: 7 Years to 11 Years

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.

+Locations (1)

Facility	City	Country	Status
Hôpital Pitié-Salpêtrière	Paris	France

+Publications

Results publication: 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

+Investigators

David Cohen, Principal investigator, Hôpital Pitié-Salpêtrière, Paris, France