Clinical trial NCT05838261: Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements in Velopharyngeal Insufficiency
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate
Keywords: Velopharyngeal insufficiency
Pharyngeal flap
Patient- and parent-reported outcome measurements
Cleft palate
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Uppsala University Hospital
name: University Hospital, Linkoeping
name: Skane University Hospital
name: Sahlgrenska University Hospital
First posted: 2023-05-01
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Speech function
timeFrame: Change in speech function will be evaluated preoperatively and 1 year postoperatively
measure: Speech function
timeFrame: Change in speech function will be evaluated preoperatively and 1 year postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Malmö
country: Sweden
facility: Skånes University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Umeå
country: Sweden
facility: Plastic Surgery Unit, Umeå University hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Umeå University
name: Rebecca Wiberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: