Evaluating speech function in children with cleft palate
Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements Following Surgical Treatment of Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate
Umeå University · NCT05838261
This study is testing how well pharyngeal flap surgery improves speech in children with cleft palate and whether it helps them communicate better and feel less stigmatized.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 0 Years to 17 Years |
| Sex | All |
| Sponsor | Umeå University (other) |
| Locations | 6 sites (Gothenburg and 5 other locations) |
| Trial ID | NCT05838261 on ClinicalTrials.gov |
What this trial studies
This study evaluates speech function in children with velopharyngeal insufficiency (VPI) who are undergoing pharyngeal flap surgery. It focuses on collecting patient- and parent-reported outcome measurements to assess the impact of the surgery on speech and communication. The study aims to understand the effectiveness of surgical interventions in improving speech outcomes and reducing social stigmatization associated with VPI. Participants will include children under 18 years old with isolated or combined cleft palate from specialized cleft centers in Sweden.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years old with isolated or combined cleft palate who are scheduled for pharyngeal flap surgery.
Not a fit: Patients with cognitive impairments that hinder their understanding of the study will not benefit from this research.
Why it matters
Potential benefit: If successful, this study could lead to improved speech outcomes and quality of life for children with cleft palate.
How similar studies have performed: Other studies have shown success in evaluating speech outcomes following surgical interventions for cleft palate, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All children \< 18 years of age with isolated or combined cleft palate that will undergo pharyngeal flap surgery due to velopharyngeal insufficiency, as well as their parents, in any of the 6 specialized cleft center in Sweden. Exclusion Criteria: * Cognitive impairment making it difficult to understand the study.
Where this trial is running
Gothenburg and 5 other locations
- Sahlgrenska University Hospital — Gothenburg, Sweden (NOT_YET_RECRUITING)
- Linköping University Hospital — Linköping, Sweden (NOT_YET_RECRUITING)
- Skånes University Hospital — Malmö, Sweden (RECRUITING)
- Karolinska University Hospital — Stockholm, Sweden (RECRUITING)
- Plastic Surgery Unit, Umeå University hospital — Umeå, Sweden (RECRUITING)
- Uppsala University Hospital — Uppsala, Sweden (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Rebecca Wiberg, MD PhD — Umeå University
- Study coordinator: Rebecca Wiberg, MD PhD
- Email: rebecka.wiberg@umu.se
- Phone: +46907850000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate, Velopharyngeal insufficiency, Pharyngeal flap, Patient- and parent-reported outcome measurements, Cleft palate