Examining the Effect of a Digital MD for Cognitive and Musical Training + Reduced Conventional SOC on the Reading and Writing Skills of Pediatric Participants With a Specific Learning Disability With Reading and/or Written Expression Deficit vs a Control Group Receiving Conventional SOC.

NCT06592911 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2026-02-05

No results posted yet for this study

Summary

Poppins-02 is a multicentric randomized non-inferiority study examining the effect of the digital medical device Poppins Clinical for cognitive and musical training in addition to bi-monthly speech and reading therapy sessions on the reading and writing skills of pediatric participants with a specific learning disability with reading and/or written expression deficit.

Participants will be assigned randomly either to an experimental group that will use the medical device in combination with reduced speech and reading therapy sessions (1 session each 2 weeks) or to the control group receiving conventional standard of care, i.e. 1 speech and reading therapy sessions per week.

Conditions

  • Learning Disorder, Specific
  • Learning Disability
  • Specific Learning Disorder, With Impairment in Reading
  • Dyslexia

Interventions

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.

Sponsors & Collaborators

  • Lindus Health

    collaborator INDUSTRY
  • Poppins

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2026-01-29
Completion
2026-01-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06592911 on ClinicalTrials.gov