NCT06105099 Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate
| NCT ID | NCT06105099 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Cleft Palate Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2022-10-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Speech therapy in children with a palate deals with two scientific challenges that will be addressed in this project. The first challenge is selecting the best speech approach for a child with a specific cleft speech characteristic (CSC). Many speech therapists use a 'one-size-fits-all' approach to treat compensatory CSCs resulting in poor short- and long-term speech outcomes. To increase the effectiveness and quality of cleft speech care, it is necessary to find the best match between a specific therapy and a given type of CSC. Therefore, this proposal will compare the effect of 3 different speech approaches on the speech and quality of life in Dutch speaking children with different types of CSCs. The second challenge is selecting the best speech approach to enhance long-term learning and transfer of newly established speech skills to untrained consonants. To date, research mainly focused on immediate therapy effects. It is unknown if permanent speech changes occur. Hence, this project will also investigate the short-term and long-term learning effects (retention and transfer) of the different speech approaches from the first objective. This proposal will improve evidence-based and patient-tailored cleft speech therapy.
Eligibility Criteria
Inclusion Criteria: * Belgian Dutch-speaking children with a cleft palate with or without a cleft lip * Aged between 4 and 12 years * Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist Exclusion Criteria: * Children with syndromic clefts * Oronasal fistula * Velopharyngeal insufficiency * Hearing disabilities based on pure tone audiometry (\>25 dB HL) * Cognitive and/or related learning disabilities or neuromuscular disorders
Frequently Asked Questions
Who can join the NCT06105099 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 12 Years, studying Cleft Palate Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06105099 currently recruiting?
Yes, NCT06105099 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Ghent to inquire about joining.
Where is the NCT06105099 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06105099 clinical trial?
NCT06105099 is sponsored by University Ghent. The trial plans to enroll 135 participants.