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Search / Trial NCT05838261

Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements in Velopharyngeal Insufficiency

Launched by UMEÅ UNIVERSITY · Apr 20, 2023

Trial Information

Current as of August 24, 2025

Recruiting

Keywords

Velopharyngeal Insufficiency Pharyngeal Flap Patient And Parent Reported Outcome Measurements Cleft Palate

ClinConnect Summary

This clinical trial is looking at how well speech function improves after surgery in children with a condition called velopharyngeal insufficiency (VPI), which often occurs in those born with cleft lip and/or palate. VPI makes it hard for children to close off the nasal passage when they talk, leading to problems with speech clarity and social interactions. The study aims to gather feedback from both the children undergoing surgery and their parents to better understand how effective the surgery is in improving speech.

To be eligible for this trial, children under 18 years old who have isolated or combined cleft palate and are scheduled for a specific type of surgery called pharyngeal flap surgery can participate. The study is currently recruiting participants across six specialized cleft centers in Sweden. Parents and their children who join the study will be asked to share their experiences and observations about speech changes after the surgery. This information will help doctors understand who benefits most from these surgical treatments and improve care for future patients.

Gender

ALL

Eligibility 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.

About Umeå University

Umeå University, a leading research institution in Sweden, is dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on interdisciplinary collaboration, the university harnesses cutting-edge technology and expert knowledge across various fields to address critical health challenges. Its commitment to ethical standards and patient safety ensures that all clinical trials conducted under its auspices are designed to generate robust scientific evidence, ultimately contributing to improved health outcomes and informed medical practices. Umeå University strives to foster a dynamic research environment that supports the development of new therapies and enhances the understanding of complex health issues.

Locations

Uppsala, , Sweden

Göteborg, , Sweden

Stockholm, , Sweden

Linköping, , Sweden

Umeå, , Sweden

Malmö, , Sweden

Patients applied

0 patients applied

Trial Officials

Rebecca Wiberg, MD PhD

Principal Investigator

Umeå University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported