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NCT05838261
Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements in Velopharyngeal Insufficiency
trial testing Pharyngeal flap in Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate in 50 participants. Currently enrolling.
1 January 2026
Quick facts
| Lead sponsor | Umeå University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 24 August 2022 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 January 2026 |
| Sites | 6 locations across Sweden |
Drugs / interventions tested
- Pharyngeal flap
Conditions studied
- Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate — all drugs for Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate →
Sponsor
Umeå University
Who can join
Adults 0 to 17, any sex, with Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05838261 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Umeå University
- Last refreshed: 8 May 2024
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