Learning Disorder, SpecificPOPPINS-02NCT06592911
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.
A study testing Poppins Clinical in people with Learning Disorder, Specific and Learning Disability, run by Poppins at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Learning Disorder, Specific, Learning Disability, 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
- 306 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Dec 2024to 29 Jan 2026
- 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). 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;
- Subject receiving speech and reading therapy for less than 2 years, receiving speech and reading therapy for written language for less than 2 years, with a maximum treatment frequency of one session per week, either for at least 3 months for children followed for more than 3 months, or for the duration of the treatment for children followed for less than 3 months.;
- 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 (Sécurité 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 a previous version (Mila-Learn);
- Unstabilized chronic illness (at investigator's discretion);
- Participants with autism spectrum disorders or documented intellectual disabilities;
- Vision or Hearing difficulties preventing the use of the tablet or smartphone;
- Any condition that, in the opinion of the investigator, may prevent the patient from participating in the trial
- Participant actively participating in an interventional study that may affect results.
- Concurrent participation of any other family member in the same clinical trial
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Pitié-Salpêtrière, Paris, Paris 75013
Paris, 75013
Hôpital Henri Laborit Poitiers, 86000
Poitiers, 86000
About this study
Official title: 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 Compared With a Control Group Receiving Weekly Speech and Reading Therapy Sessions.
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.
Read the detailed description
The study is a multicentric randomized non-inferiority clinical trial that has the aim to evaluate the impact of the digital medical device Poppins Clinical in addition to reduced speech and reading therapy sessions on children aged 7 to 11 years on their reading and writing skills.
Poppins Clinical is a software as a medical device (saMD) that combines a musical and cognitive training program and a written language training program. It is intended to provide a therapeutic rehabilitation for children with Specific Learning Disorders (SLD) with reading deficit. Poppins Clinical saMD operates on a tablet or smartphone and is designed to offer a fun and interactive gaming experience for children in form of a serious game.
The POPPINS-02 study thus proposes to include two patient arms:
- The experimental arm benefiting from Poppins Clinical training during 12 weeks in addition to reduced conventional speech and reading therapy (1 session each 2 weeks),
- The control arm having only conventional speech and reading therapy (1 session per week) during 12 weeks.
A randomization list will be generated, directing patients to the experimental or control arm, and informing parents, the patient, and the speech and reading therapist after the first pre-test. The investigator and his team will be blinded to the patient allocation group. It is therefore a single-blind study since parents, patients, and speech and reading therapists will be aware of the randomization.
In the experimental group, patients will have access to training with Poppins Clinical for 5 sessions per week, each session lasting approximately 20 minutes.
- Conditions
- Learning Disorder, Specific, Learning Disability, 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 |
|---|---|---|
| CONTROL | No intervention | 1 session of speech and reading therapy weekly, no use of the medical device Poppins Clinical |
| EXPERIMENTAL | Experimental | Reduced speech and reading therapy sessions (1 session every 2 weeks) and use of the medical device Poppins Clinical Receives: Device: Poppins Clinical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the non-inferiority of Poppins Clinical as a complement to reduced speech and reading therapy compared to only speech and reading therapy.
This endpoint evaluates the non-inferiority on reading abilities using a word reading task measured by the EVALEO 2-minute word reading test (EVAL2M) and measuring the number of correctly read words.
Measured: 12 weeks
Secondary outcomes (8)
Secondary safety objective
any adverse events will be collected from participants.
Evaluation of adverse events reported by participants
Measured: 12 weeks
Secondary objective 1: Evaluate the effect of adding Poppins Clinical on reading abilities in terms of speed (non-inferiority)
This endpoint evaluates the non-inferiority on reading abilities using a word reading task measured by the EVALEO 2-minute word reading test (EVAL2M) and measuring the number of read words.
Measured: 12 weeks
Secondary objective 2: Evaluate the effect of adding Poppins Clinical on text reading skills (non-inferiority)
This endpoint evaluates the effect of the addition of Poppins Clinical on word reading skills in terms of speed and accuracy as assessed by a text reading test (Alouette).
Measured: 12 weeks
Secondary objective 3: description and evaluation of the coast associated to children's treatment
This endpoint evaluates the coasts related to the medical care between the two groups, based on the number of treatment sessions, cost per session, cost of the medical device and travel cost, using a custom-made questionnaire
Measured: 12 weeks
Secondary objective 4: Evaluation of the effect of adding Poppins Clinical on the parents' stress level between the two groups (EXPE/CONT) (non-inferiority)
This endpoint examines the impact of adding Poppins Clinical on parents' stress levels, measured using the parenting stress index short form
Measured: 12 weeks
Secondary objective 5: Description and comparison of the effect of adding Poppins Clinical on the parents' quality of life between the two groups (EXPE/CONT) (non-inferiority)
This endpoint examines the impact of adding Poppins Clinical on parents' quality of life, measured using the EQ-5D-5L quality of life questionnaire
Measured: 12 weeks
Secondary outcome 6: evaluate the effect of adding Poppins Clinical on meta-phonological skills between the two groups (EXPE/CONT) (non-inferiority)
This endpoint evaluates the effect of adding Poppins Clinical on meta-phonological skills as assessed by the BALE phoneme suppression test (correct answers score)
Measured: 12 weeks
Secondary objective 7: Evaluate the effect of adding Poppins Clinical on text comprehension (non-inferiority)
This endpoint evaluates at the effect of adding Poppins Clinical on text comprehension assessed using the computerized adaptable test battery (BMT-i)
Measured: 12 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 start20 Dec 2024
- Primary completion29 Jan 2026
- Study completion29 Jan 2026
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 Disorder, 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric randomized non-inferiority study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poppins
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592911
- Sponsor's protocol ID
- POPPINS-02
- Acronym
- POPPINS-02
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grossard C, Descamps M, Cadoni S, Pellerin H, Vonthron F, Xavier J, Falissard B, Cohen D. Assessing the Noninferiority of a Rhythm and Language Training Serious Game Combined With Speech Therapy Versus Speech Therapy Care for Children With Dyslexia: Protocol for an Investigator-Blinded Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 3;14:e71326. doi: 10.2196/71326.
PubMed 40179385
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Compared With a Control Group Receiving Weekly Speech and Reading Therapy Sessions.
- ClinicalTrials.gov ID
- NCT06592911
- Acronym / sponsor ID
- POPPINS-02 / POPPINS-02
- Conditions
- Learning Disorder, Specific, Learning Disability, Specific Learning Disorder, With Impairment in Reading, Dyslexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- PoppinsIndustry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (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.
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.
Detailed description
The study is a multicentric randomized non-inferiority clinical trial that has the aim to evaluate the impact of the digital medical device Poppins Clinical in addition to reduced speech and reading therapy sessions on children aged 7 to 11 years on their reading and writing skills.
Poppins Clinical is a software as a medical device (saMD) that combines a musical and cognitive training program and a written language training program. It is intended to provide a therapeutic rehabilitation for children with Specific Learning Disorders (SLD) with reading deficit. Poppins Clinical saMD operates on a tablet or smartphone and is designed to offer a fun and interactive gaming experience for children in form of a serious game.
The POPPINS-02 study thus proposes to include two patient arms:
- The experimental arm benefiting from Poppins Clinical training during 12 weeks in addition to reduced conventional speech and reading therapy (1 session each 2 weeks),
- The control arm having only conventional speech and reading therapy (1 session per week) during 12 weeks.
A randomization list will be generated, directing patients to the experimental or control arm, and informing parents, the patient, and the speech and reading therapist after the first pre-test. The investigator and his team will be blinded to the patient allocation group. It is therefore a single-blind study since parents, patients, and speech and reading therapists will be aware of the randomization.
In the experimental group, patients will have access to training with Poppins Clinical for 5 sessions per week, each session lasting approximately 20 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentric randomized non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –1 session of speech and reading therapy weekly, no use of the medical device Poppins Clinical |
| EXPERIMENTAL | Experimental | Device: Poppins ClinicalReduced speech and reading therapy sessions (1 session every 2 weeks) and use of the medical device Poppins Clinical |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 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). 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;
- Subject receiving speech and reading therapy for less than 2 years, receiving speech and reading therapy for written language for less than 2 years, with a maximum treatment frequency of one session per week, either for at least 3 months for children followed for more than 3 months, or for the duration of the treatment for children followed for less than 3 months.;
- French mother tongue or French bilingualism at home and more than 3 years schooling in France;
- Tablet or smartphone available at home;
Key exclusion criteria (7 listed)
- Subject has previously used Poppins Clinical or a previous version (Mila-Learn);
- Unstabilized chronic illness (at investigator's discretion);
- Participants with autism spectrum disorders or documented intellectual disabilities;
- Vision or Hearing difficulties preventing the use of the tablet or smartphone;
- Any condition that, in the opinion of the investigator, may prevent the patient from participating in the trial
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 | EXPERIMENTAL |
Primary outcome
Evaluate the non-inferiority of Poppins Clinical as a complement to reduced speech and reading therapy compared to only speech and reading therapy.
Time frame: 12 weeks
This endpoint evaluates the non-inferiority on reading abilities using a word reading task measured by the EVALEO 2-minute word reading test (EVAL2M) and measuring the number of correctly read words.
8 secondary outcomes
Secondary safety objective
Time frame: 12 weeks
Secondary objective 1: Evaluate the effect of adding Poppins Clinical on reading abilities in terms of speed (non-inferiority)
Time frame: 12 weeks
Secondary objective 2: Evaluate the effect of adding Poppins Clinical on text reading skills (non-inferiority)
Time frame: 12 weeks
Secondary objective 3: description and evaluation of the coast associated to children's treatment
Time frame: 12 weeks
Secondary objective 4: Evaluation of the effect of adding Poppins Clinical on the parents' stress level between the two groups (EXPE/CONT) (non-inferiority)
Time frame: 12 weeks
Secondary objective 5: Description and comparison of the effect of adding Poppins Clinical on the parents' quality of life between the two groups (EXPE/CONT) (non-inferiority)
Time frame: 12 weeks
Secondary outcome 6: evaluate the effect of adding Poppins Clinical on meta-phonological skills between the two groups (EXPE/CONT) (non-inferiority)
Time frame: 12 weeks
Secondary objective 7: Evaluate the effect of adding Poppins Clinical on text comprehension (non-inferiority)
Time frame: 12 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 5 Feb 2026.
- Derived from this study: PubMed 40179385Grossard C, Descamps M, Cadoni S, Pellerin H, Vonthron F, Xavier J, Falissard B, Cohen D. Assessing the Noninferiority of a Rhythm and Language Training Serious Game Combined With Speech Therapy Versus Speech Therapy Care for Children With Dyslexia: Protocol for an Investigator-Blinded Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 3;14:e71326. doi: 10.2196/71326.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Disorder, Specific and Learning Disability, run by Poppins at 2 sites 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 7 inclusion and 7 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 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Evaluate the non-inferiority of Poppins Clinical as a complement to reduced speech and reading therapy compared to only speech and reading therapy. (time frame: 12 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 NCT06592911, 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 5 Feb 2026.