Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements in Velopharyngeal Insufficiency
NCT ID: NCT05838261
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2022-08-24
2026-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Pharyngeal 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.
Interventions
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Pharyngeal 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
0 Years
17 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Uppsala University Hospital
OTHER
University Hospital, Linkoeping
OTHER
Skane University Hospital
OTHER
Sahlgrenska University Hospital
OTHER
Umeå University
OTHER
Responsible Party
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Rebecka Wiberg
Principal Investigator
Principal Investigators
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Rebecca Wiberg, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Umeå University
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Linköping University Hospital
Linköping, , Sweden
Skånes University Hospital
Malmo, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Plastic Surgery Unit, Umeå University hospital
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Patrik Boivie, MD PhD
Role: primary
Louise Rydén, MD PhD
Role: primary
Malin Schaar Johansson
Role: primary
Björn Schönmeyr, MD PhD
Role: primary
Malin Hakelius, MD PhD
Role: primary
Åsa Okhiria, PhD
Role: backup
Other Identifiers
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2023-VPI-RWiberg
Identifier Type: -
Identifier Source: org_study_id
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