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RECRUITING
NCT05838261

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

Sponsor: Umeå University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

0 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2022-08-24

Completion Date

2026-01-01

Last Updated

2024-05-08

Healthy Volunteers

Not specified

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.

Locations (6)

Sahlgrenska University Hospital

Gothenburg, Sweden

Linköping University Hospital

Linköping, Sweden

Skånes University Hospital

Malmo, Sweden

Karolinska University Hospital

Stockholm, Sweden

Plastic Surgery Unit, Umeå University hospital

Umeå, Sweden

Uppsala University Hospital

Uppsala, Sweden