Learning Disorder, SpecificPOPPINS-02-BNCT06902610
Examining the Medium-term Effect on Non Inferiority of the Previous Training With the DMD Poppins Clinical for Cognitive, Musical Training in Addition to Bi-monthly Speech and Reading Therapy on Reading Writing Abilities of Pediatric Patients With SLD Reading VS Control Group
An observational study of Learning Disorder, Specific and Learning Disability, run by Poppins at 2 sites in France.
Trial summary
Poppins-02-b is an observational follow-up study examining the medium-term effect on non-inferiority of the previous training with the digital medical device (DMN) Poppins Clinical for cognitive and musical training in addition to bi-monthly speech and reading therapy sessions on the reading and writing abilities of… 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
- How many people
- 306 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Jun 2025to 10 Jun 2026
- Phase
- Observational
- 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
Study population: According to the DSM-5-TR or ICD-11 Specific Learning Disability (SLD) or Developmental Learning Disability (DLD) is one of the most common neurodevelopmental disorders. It affects between 5% and 15% of schoolchildren. In particular, SLD is one of the most common neurodevelopmental disorders. It affects between 6% and 8% of schoolchildren. It is characterized by significant and persistent difficulties in the acquisition of academic skills, which may include reading, writing or arithmetic, although dyslexia is by far the most common type, accounting for 80% of SLD. SLD first manifests itself during the teaching of academic or occupational functioning. Children with SLD do not have associated intellectual retardation, overt brain damage or degenerative disorders. They are therefore likely to benefit most from remediation.
Who may be able to join
- Subjects must meet all of the following inclusion criteria:
- Patient who has been enrolled in the POPPINS-02 study.
- Participation agreement from the patient as well as from the legal guardians, and commitment to follow the protocol.
Who cannot join
- Any pathology that, at the discretion of the investigator, may prevent the patient from participating in the study.
- Patient participating in an interventional study that could affect the results.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Pitié-Salpêtrière
Paris, 75013
Hôpital Henri Laborit
Poitiers, 86000
About this study
Official title: Observational Follow-up Study Examining the Medium-term Effect on Non-inferiority of the Previous Training With the Digital Medical Device (DMD) Poppins Clinical for Cognitive and Musical Training in Addition to Bi-monthly Speech and Reading Therapy Sessions on the Reading and Writing Abilities of Pediatric Patients With Specific Learning Disorders Involving Reading and/or Writing Deficits (SLD Reading) Compared to a Control Group Receiving Weekly Speech and Reading Therapy Sessions (POPPINS-02-b, Ancillary Study to POPPINS-02)
Poppins-02-b is an observational follow-up study examining the medium-term effect on non-inferiority of the previous training with the digital medical device (DMN) Poppins Clinical for cognitive and musical training in addition to bi-monthly speech and reading therapy sessions on the reading and writing abilities of pediatrics patients with specific learning disorders involving reading and/or writing deficits compared to a control group that received weekly speech and reading therapy sessions.
Poppins-02-b is an ancillary study to Poppins-02 and consists of monitoring patients who participated in Poppins-02 study.
Read the detailed description
The POPPINS-02-b follow-up study consists in following up patients who took part in the POPPINS-02 clinical trial: a randomized non-inferiority trial with a control group designed to assess the effect of adding the Poppins Clinical digital medical device in addition to bi-monthly speech and reading therapy sessions on the skills of patients with reading disorders. Patients included in the original POPPINS-02 study were randomized into one of two groups:
- Experimental group (EXPE group): will receive the Poppins Clinical digital medical device in addition to bi-monthly speech and reading therapy sessions.
- Control group (CONT group): will receive weekly speech and reading therapy sessions.
In the original POPPINS-02 study, the experimental phase lasts 12 weeks in total, with a preliminary evaluation (T1) and a final evaluation (T2) after this period.
All patients enrolled in the POPPINS-02 study will be included, if they so wish, in the POPPINS-02-b follow-up study. This study consists of a 12-week follow-up phase after the final POPPINS-02 protocol visit (T2). During this follow-up phase, all patients will return to their usual speech therapy management with the frequency planned before their participation in POPPINS-02. During this follow-up phase, patients in both groups will not have access to the Poppins Clinical application. At the end of the 12-week follow-up period, an evaluation (T3) is scheduled. Assessments will cover primary, secondary and exploratory endpoints.
A questionnaire will also be submitted to parents and speech therapists caring for the children during T3 in order to collect information on the dates of speech therapy sessions during this follow-up period, and to benefit from their perspective on the medium-term effect of the study protocol on speech therapy follow-up.
Access to the Poppins Clinical digital medical device will be offered to children in the two POPPINS-02 study groups who decide to participate in the POPPINS-02-b follow-up study at the end of the experiment.
The investigator and his team will remain blind as to which groups will be assigned to the POPPINS-02 study.
- 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 combines a musical and cognitive training program and written language training program.
| Study group | Role | What they receive |
|---|---|---|
| No intervention: CONTROL | 1 session of speech and reading therapy weekly, no use of the medical device Poppins Clinical | |
| 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 medium term 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 2-minutes word reading rest form EVALEO (EVAL2M), assessing the number of words correctly read, 12 weeks after the last evaluation of the POPPINS-02 study
Measured: 12 weeks
Secondary outcomes (6)
Evaluate the medium-term effect of adding Poppins Clinical on reading abilities (in terms of reading speed) (non-inferiority).
This endpoint evaluates the non-inferiority on reading abilities using a word reading task measured by the 2-minute word reading test from EVALEO (EVAL2M), assessing the number of words read, 12 weeks after the last evaluation of the POPPINS-02 study.
Measured: 12 weeks
Evaluate the medium-term effect of adding Poppins Clinical on text reading skills (non-inferiority).
This endpoint evaluates the mid-term 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) (speed and accuracy scores), 12 weeks after the last evaluation of the POPPINS-02 study.
Measured: 12 weeks
Assessment of the medium-term effect of adding Poppins Clinical on parental stress level between the two groups (EXP/CONT) (non-inferiority).
This endpoint examines the mid-term impact of adding Poppins Clinical on parents' stress levels, measured using the parenting stress index short form, 12 weeks after the last evaluation of the POPPINS-02 study.
Measured: 12 weeks
Description and comparison of the medium-term effect of adding Poppins Clinical on the quality of life of parents between the two groups (EXP/CONT) (non-inferiority).
This endpoint examines the mid-term impact of adding Poppins Clinical on parents' quality of life, measured using the EQ-5D-5L quality of life questionnaire, 12 weeks after the last evaluation of the POPPINS-02 study.
Measured: 12 weeks
Evaluate the medium-term effect of adding Poppins Clinical on metaphonological skills (non-inferiority).
This endpoint evaluates the mid-term effect of adding Poppins Clinical on meta-phonological skills as assessed by the BALE phoneme suppression test (correct answers score), 12 weeks after the last evaluation of the POPPINS-02 study.
Measured: 12 weeks
Evaluate the medium-term effect of adding Poppins Clinical on text comprehension (non-inferiority).
This endpoint evaluates at the mid-term effect of adding Poppins Clinical on text comprehension assessed using the computerized adaptable test battery (BMT-i) (evaluated scores: correct answers to text comprehension questions score, reading precision and speed), 12 weeks after the last evaluation of the POPPINS-02 study.
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 posted30 Mar 2025
- Study start20 Jun 2025
- Primary completion15 Apr 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- 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
- NCT06902610
- Sponsor's protocol ID
- POPPINS-02-b
- Acronym
- POPPINS-02-B
- Status last verified
- Aug 2026
- First submitted
- 24 Mar 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Follow-up Study Examining the Medium-term Effect on Non-inferiority of the Previous Training With the Digital Medical Device (DMD) Poppins Clinical for Cognitive and Musical Training in Addition to Bi-monthly Speech and Reading Therapy Sessions on the Reading and Writing Abilities of Pediatric Patients With Specific Learning Disorders Involving Reading and/or Writing Deficits (SLD Reading) Compared to a Control Group Receiving Weekly Speech and Reading Therapy Sessions (POPPINS-02-b, Ancillary Study to POPPINS-02)
- ClinicalTrials.gov ID
- NCT06902610
- Acronym / sponsor ID
- POPPINS-02-B / POPPINS-02-b
- Conditions
- Learning Disorder, Specific, Learning Disability, Specific Learning Disorder, With Impairment in Reading, Dyslexia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- PoppinsIndustry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 30 Mar 2025 (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-b is an observational follow-up study examining the medium-term effect on non-inferiority of the previous training with the digital medical device (DMN) Poppins Clinical for cognitive and musical training in addition to bi-monthly speech and reading therapy sessions on the reading and writing abilities of pediatrics patients with specific learning disorders involving reading and/or writing deficits compared to a control group that received weekly speech and reading therapy sessions.
Poppins-02-b is an ancillary study to Poppins-02 and consists of monitoring patients who participated in Poppins-02 study.
Detailed description
The POPPINS-02-b follow-up study consists in following up patients who took part in the POPPINS-02 clinical trial: a randomized non-inferiority trial with a control group designed to assess the effect of adding the Poppins Clinical digital medical device in addition to bi-monthly speech and reading therapy sessions on the skills of patients with reading disorders. Patients included in the original POPPINS-02 study were randomized into one of two groups:
- Experimental group (EXPE group): will receive the Poppins Clinical digital medical device in addition to bi-monthly speech and reading therapy sessions.
- Control group (CONT group): will receive weekly speech and reading therapy sessions.
In the original POPPINS-02 study, the experimental phase lasts 12 weeks in total, with a preliminary evaluation (T1) and a final evaluation (T2) after this period.
All patients enrolled in the POPPINS-02 study will be included, if they so wish, in the POPPINS-02-b follow-up study. This study consists of a 12-week follow-up phase after the final POPPINS-02 protocol visit (T2). During this follow-up phase, all patients will return to their usual speech therapy management with the frequency planned before their participation in POPPINS-02. During this follow-up phase, patients in both groups will not have access to the Poppins Clinical application. At the end of the 12-week follow-up period, an evaluation (T3) is scheduled. Assessments will cover primary, secondary and exploratory endpoints.
A questionnaire will also be submitted to parents and speech therapists caring for the children during T3 in order to collect information on the dates of speech therapy sessions during this follow-up period, and to benefit from their perspective on the medium-term effect of the study protocol on speech therapy follow-up.
Access to the Poppins Clinical digital medical device will be offered to children in the two POPPINS-02 study groups who decide to participate in the POPPINS-02-b follow-up study at the end of the experiment.
The investigator and his team will remain blind as to which groups will be assigned to the POPPINS-02 study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention: CONTROL | – | –1 session of speech and reading therapy weekly, no use of the medical device Poppins Clinical |
| 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
- Study population
- According to the DSM-5-TR or ICD-11 Specific Learning Disability (SLD) or Developmental Learning Disability (DLD) is one of the most common neurodevelopmental disorders. It affects between 5% and 15% of schoolchildren. In particular, SLD is one of the most common neurodevelopmental disorders. It affects between 6% and 8% of schoolchildren. It is characterized by significant and persistent difficulties in the acquisition of academic skills, which may include reading, writing or arithmetic, although dyslexia is by far the most common type, accounting for 80% of SLD. SLD first manifests itself during the teaching of academic or occupational functioning. Children with SLD do not have associated intellectual retardation, overt brain damage or degenerative disorders. They are therefore likely to benefit most from remediation.
Key inclusion criteria (3 listed)
- Subjects must meet all of the following inclusion criteria:
- Patient who has been enrolled in the POPPINS-02 study.
- Participation agreement from the patient as well as from the legal guardians, and commitment to follow the protocol.
Key exclusion criteria (2 listed)
- Any pathology that, at the discretion of the investigator, may prevent the patient from participating in the study.
- Patient participating in an interventional study that could affect the 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 combines a musical and cognitive training program and written language training program. | Device | Experimental |
Primary outcome
Evaluate the medium term 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 2-minutes word reading rest form EVALEO (EVAL2M), assessing the number of words correctly read, 12 weeks after the last evaluation of the POPPINS-02 study
6 secondary outcomes
Evaluate the medium-term effect of adding Poppins Clinical on reading abilities (in terms of reading speed) (non-inferiority).
Time frame: 12 weeks
Evaluate the medium-term effect of adding Poppins Clinical on text reading skills (non-inferiority).
Time frame: 12 weeks
Assessment of the medium-term effect of adding Poppins Clinical on parental stress level between the two groups (EXP/CONT) (non-inferiority).
Time frame: 12 weeks
Description and comparison of the medium-term effect of adding Poppins Clinical on the quality of life of parents between the two groups (EXP/CONT) (non-inferiority).
Time frame: 12 weeks
Evaluate the medium-term effect of adding Poppins Clinical on metaphonological skills (non-inferiority).
Time frame: 12 weeks
Evaluate the medium-term 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 21 Aug 2026.
- 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?
An observational study of 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 3 inclusion and 2 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 21 Aug 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 medium term 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?
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 21 Aug 2026.