NCT05838261

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-24
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2023-05-01
• Last updated: 2024-05-08

Locations

6 sites across 1 country: Sweden