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

Overview

Cleft lip and/or palate (CL/P) is the most common congenital malformation, with about one in 500 children born with CL/P in Sweden, corresponding to approximately 175 births annually. Depending on the extent of the cleft palate, the degree of functional loss varies, but both eating, hearing, speech, bite and appearance can be affected. Patients treated for isolated or combined cleft palate may suffer from velopharyngeal insufficiency (VPI), which means difficulties in closing the passage between the oral and nasal cavities during speech. Velopharyngeal insufficiency is associated with hypernasality, audible nasal air leakage and weak articulation, which might lead to difficulties with communication and social stigmatization. The most common form of speech-improving surgery is a posterior based velopharyngeal flap, creating a bridge between the palate and the posterior pharyngeal wall to more easily compensate for the abnormal airflow through the nose during speech. However, surgical management of VPI is challenging, with variable success rates reported in the literature. In a retrospectively based questionnaire study on patients who underwent surgical treatment of VPI, 30% experienced only a small speech improvement or no improvement at all. In addition, postoperative speech impairment have also been reported, as well as perioperative bleeding and postoperative sleep apnea. Thus, selecting the patients who benefit most from speech-improving surgery is therefore of great importance. The aim with the current study is 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.

Full Title of Study: “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”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: January 1, 2026

Interventions

• Procedure: Pharyngeal flap
  • Children with combined or isolated cleft palate with velopharyngeal insufficiency undergoing surgical treatment with pharyngeal flap will be evaluated with patient- and parent reported outcome measures before and after the surgery.

Arms, Groups and Cohorts

• Children with cleft palate with velopharyngeal insufficiency undergoing surgical treatment
  • Children with combined or isolated cleft palate with velopharyngeal insufficiency undergoing surgical treatment with pharyngeal flap

Clinical Trial Outcome Measures

Primary Measures

• Speech function
  • Time Frame: Change in speech function will be evaluated preoperatively and 1 year postoperatively
  • Speech function will be evaluated through the patient response outcome measurement CLEFT-Q pre- and postoperatively. Each CLEFT-Q scale is transformed into scores that range from 0-100, with higher scores reflecting a better outcome.
• Speech function
  • Time Frame: Change in speech function will be evaluated preoperatively and 1 year postoperatively.
  • Speech function will be evaluated through the parent-response outcome measurement Intelligibility in Context Scale pre- and postoperatively. The maximum and minimum value ranges from 0-35 respectively, with higher scores reflecting a better outcome.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 0 Years

Maximum Age: 17 Years

Investigator Details

• Lead Sponsor
  • Umeå University
• Collaborator
  • Karolinska University Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Rebecka Wiberg, Principal Investigator – Umeå University
• Overall Official(s)
  • Rebecca Wiberg, MD PhD, Principal Investigator, Umeå University
• Overall Contact(s)
  • Rebecca Wiberg, MD PhD, +46907850000, rebecka.wiberg@umu.se