Actively Recruiting

Age: 0Years - 17Years
All Genders
NCT05838261

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

Age: 0Years - 17Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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