Actively Recruiting
Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements in Velopharyngeal Insufficiency
Led by Umeå University · Updated on 2024-05-08
50
Participants Needed
6
Research Sites
175 weeks
Total Duration
On this page
Sponsors
U
Umeå University
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements in Velopharyngeal Insufficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children under 18 years old with isolated or combined cleft palate
- Scheduled for pharyngeal flap surgery due to velopharyngeal insufficiency
- Patients and their parents receiving care at one of the six specialized cleft centers in Sweden
You will not qualify if you...
- Cognitive impairment that makes it difficult to understand the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden
Not Yet Recruiting
2
Linköping University Hospital
Linköping, Sweden
Not Yet Recruiting
3
Skånes University Hospital
Malmö, Sweden
Actively Recruiting
4
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
5
Plastic Surgery Unit, Umeå University hospital
Umeå, Sweden
Actively Recruiting
6
Uppsala University Hospital
Uppsala, Sweden
Not Yet Recruiting
Research Team
R
Rebecca Wiberg, MD PhD
CONTACT
J
Jenny Cajander, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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