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

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.

Study Overview

• Status: Recruiting
• Conditions: Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate
• Intervention / Treatment: Procedure: Pharyngeal flap

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Rebecca Wiberg, MD PhD; Phone Number: +46907850000; Email: rebecka.wiberg@umu.se
• Study Contact Backup: Name: Jenny Cajander, MD; Phone Number: +46907850000; Email: jenny.cajander@umu.se

Study Locations

• Sweden
  • Göteborg, Sweden
    • Not yet recruiting
    • Sahlgrenska University Hospital
    • Contact: Patrik Boivie, MD PhD
  • Linköping, Sweden
    • Not yet recruiting
    • Linkoping University Hospital
    • Contact: Louise Rydén, MD PhD
  • Malmö, Sweden
    • Recruiting
    • Skånes University Hospital
    • Contact: Malin Schaar Johansson
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Contact: Björn Schönmeyr, MD PhD
  • Umeå, Sweden
    • Recruiting
    • Plastic Surgery Unit, Umeå University hospital
    • Contact: Rebecca Wiberg, MD, PhD; Phone Number: +4670-3884369; Email: anna.rebecca.wiberg@gmail.com
  • Uppsala, Sweden
    • Not yet recruiting
    • Uppsala University Hospital
    • Contact: Malin Hakelius, MD PhD
    • Contact: Åsa Okhiria, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All children < 18 years with isolated or combined cleft palate undergoing surgical treatment of velopharyngeal insufficiency in any of the 6 specialized cleft centers in Sweden will be invited to the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech function	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.	Change in speech function will be evaluated preoperatively and 1 year postoperatively
Speech function	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.	Change in speech function will be evaluated preoperatively and 1 year postoperatively.

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Karolinska University Hospital; Sahlgrenska University Hospital, Sweden; University Hospital, Linkoeping; Skane University Hospital; Uppsala University Hospital
• Investigators: Principal Investigator: Rebecca Wiberg, MD PhD, Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Cleft palate; Velopharyngeal insufficiency; Pharyngeal flap; Patient- and parent-reported outcome measurements
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Velopharyngeal Insufficiency
• Other Study ID Numbers: 2023-VPI-RWiberg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a multicenter study so the other researchers will be part of analysing the data, however only on group level.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No