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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05838261
Enrollment
50
Registered
2023-05-01
Start date
2022-08-24
Completion date
2026-01-01
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate

Keywords

Velopharyngeal insufficiency, Pharyngeal flap, Patient- and parent-reported outcome measurements, Cleft palate

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.

Interventions

PROCEDUREPharyngeal 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.

Sponsors

Karolinska University Hospital
CollaboratorOTHER
Uppsala University Hospital
CollaboratorOTHER
University Hospital, Linkoeping
CollaboratorOTHER
Skane University Hospital
CollaboratorOTHER
Sahlgrenska University Hospital
CollaboratorOTHER
Umeå University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 17 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Speech functionChange in speech function will be evaluated preoperatively and 1 year postoperativelySpeech 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.

Countries

Sweden

Contacts

Primary ContactRebecca Wiberg, MD PhD
rebecka.wiberg@umu.se+46907850000
Backup ContactJenny Cajander, MD
jenny.cajander@umu.se+46907850000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026