Clinical trial NCT06596980: Examining the Effect of a Digital Medical Device for Cognitive and Musical Training in Children With Reading Disabilities
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Learning Disorders, Specific
Learning Disabilities
Specific Learning Disorder, With Impairment in Reading
Dyslexia
Lead sponsor: Poppins
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 38
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effect of Poppins Clinical on reading abilities (accuracy)
timeFrame: 8 weeks
Secondary outcomes:
measure: Reported adverse events
timeFrame: 8 weeks
measure: Effect of Poppins Clinical on reading abilities (speed)
timeFrame: 8 weeks
measure: Effect of Poppins Clinical on phonological skills
timeFrame: 8 weeks
measure: Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (accuracy)
timeFrame: 8 weeks
measure: Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (speed)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
Study officials:
affiliation: Hôpital Pitié-Salpêtrière, Paris, France
name: David Cohen
role: PRINCIPAL_INVESTIGATOR
References: