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CompletedNCT06596980POPPINS-CEUpdated Mar 18, 2025

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

An interventional study of Poppins Clinical in Learning Disorders, Specific, Learning Disabilities and Specific Learning Disorder, With Impairment in Reading, sponsored by Poppins. Completed at 1 site in France. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Poppins · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
7 Years to 11 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Learning Disorders, Specific
  • Learning Disabilities
  • Specific Learning Disorder, With Impairment in Reading
  • Dyslexia
03

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Interventional arm

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

    Device: Poppins Clinical

Interventions

  • DevicePoppins Clinical

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

05

What researchers measure

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.

    Time frame: 8 weeks

Secondary outcomes

  1. Reported adverse events

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

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

  4. 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.

    Time frame: 8 weeks

  5. 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.

    Time frame: 8 weeks

06

Study locations

1 site
  • Hôpital Pitié-Salpêtrière
    Paris, 75013, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06596980
Lead sponsor
Poppins
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Jun 28, 2024
Primary completion
Feb 11, 2025
Completion
Feb 11, 2025
Last update
Mar 18, 2025

Study contacts

David Cohen
principal investigator · Hôpital Pitié-Salpêtrière, Paris, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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