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

Sponsor

Umeå University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05838261

Collaborator

Karolinska University Hospital (Other), Uppsala University Hospital (Other), University Hospital, Linkoeping (Other), Skane University Hospital (Other), Sahlgrenska University Hospital, Sweden (Other)

Enrollment

Locations

40.3

Anticipated Duration (Months)

8.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate	Procedure: Pharyngeal flap

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Aug 24, 2022

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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	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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Speech function [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 17 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	Country
1	Sahlgrenska University Hospital	Göteborg	Sweden
2	Linköping University Hospital	Linköping	Sweden
3	Skånes University Hospital	Malmö	Sweden
4	Karolinska University Hospital	Stockholm	Sweden
5	Plastic Surgery Unit, Umeå University hospital	Umeå	Sweden
6	Uppsala University Hospital	Uppsala	Sweden