Learning Disorders, SpecificPOPPINS-CENCT06596980
Examining the Effect of a Digital Medical Device for Cognitive and Musical Training in Children With Reading Disabilities
A study testing Poppins Clinical in people with Learning Disorders, Specific and Learning Disabilities, run by Poppins at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Learning Disorders, Specific, Learning Disabilities, Specific Learning Disorder, With Impairment in Reading
- What is being tested?
- Poppins Clinical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2024to 11 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Learning Disorders, Specific, Learning Disabilities, Specific Learning Disorder, With Impairment in Reading, Dyslexia
- Being tested
- Poppins Clinical
- Medical subject headings
- Specific Learning Disorder, Learning Disabilities, Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poppins ClinicalDevice
Poppins Clinical is a software as a medical device that combines a musical and cognitive training program and written language training program.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Use of the medical device Poppins Clinical 5 times per weeks (20 minutes training sessions) Receives: Device: Poppins Clinical |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (5)
Reported adverse events
To evaluate safety, reported adverse events during the 8 weeks follow-up phase will be evaluated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 Jun 2024
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Learning Disorders, SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poppins
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Cohen, Principal investigator, Hôpital Pitié-Salpêtrière, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596980
- Sponsor's protocol ID
- POPPINS-CE
- Other IDs
- 2024-A00432-45
- Acronym
- POPPINS-CE
- Status last verified
- Mar 2025
- First submitted
- 11 Sep 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40750096
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06596980
- Acronym / sponsor ID
- POPPINS-CE / POPPINS-CE
- Conditions
- Learning Disorders, Specific, Learning Disabilities, Specific Learning Disorder, With Impairment in Reading, Dyslexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- PoppinsIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: Poppins ClinicalUse of the medical device Poppins Clinical 5 times per weeks (20 minutes training sessions) |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poppins ClinicalPoppins Clinical is a software as a medical device that combines a musical and cognitive training program and written language training program. | Device | Interventional arm |
Primary outcome
Effect of Poppins Clinical on reading abilities (accuracy)
Time frame: 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.
5 secondary outcomes
Reported adverse events
Time frame: 8 weeks
Effect of Poppins Clinical on reading abilities (speed)
Time frame: 8 weeks
Effect of Poppins Clinical on phonological skills
Time frame: 8 weeks
Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (accuracy)
Time frame: 8 weeks
Comparison of the effect of Poppins Clinicals to a former version of the device on reading abilities (speed)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 40750096Grossard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Cohen principal investigator
Hôpital Pitié-Salpêtrière, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poppins Clinical in people with Learning Disorders, Specific and Learning Disabilities, run by Poppins at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Poppins Clinical on reading abilities (accuracy) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06596980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.