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
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 17
View:

• 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.

Locations
Other Locations
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Linköping University Hospital
NOT_YET_RECRUITING
Linköping
Skånes University Hospital
RECRUITING
Malmo
Karolinska University Hospital
RECRUITING
Stockholm
Plastic Surgery Unit, Umeå University hospital
RECRUITING
Umeå
Uppsala University Hospital
NOT_YET_RECRUITING
Uppsala
Contact Information
Primary
Rebecca Wiberg, MD PhD
rebecka.wiberg@umu.se
+46907850000
Backup
Jenny Cajander, MD
jenny.cajander@umu.se
+46907850000
Time Frame
Start Date: 2022-08-24
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 50
Treatments
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
Sponsors
Leads: Umeå University
Collaborators: Karolinska University Hospital, University Hospital, Linkoeping, Uppsala University Hospital, Sahlgrenska University Hospital, Skane University Hospital

This content was sourced from clinicaltrials.gov