← Back to all trials
Not Yet Recruiting
NCT07832812
Effect of Velopharyngeal Gap Size on Laryngeal Morphology and Vocal Function in Children With VPI
Conditions: Velopharyngeal Insufficiency
Sex: All
Ages: 4 Years – 12 Years
Healthy volunteers: Yes
Enrollment: 92
Sponsor: Assiut University
Summary
Speech production relies on the precise coordination of the respiratory, phonatory, resonatory, and articulatory systems
. The velopharyngeal mechanism is essential in separating the oral and nasal cavities during speech and swallowing. Disruption of this mechanism leads to velopharyngeal insufficiency (VPI), which is characterized by the inability to achieve complete velopharyngeal closure due to structural or anatomical deficits. VPI is frequently associated with cleft palate, either repaired or unrepaired. It may also occur secondary to submucous cleft palate (CP), craniofacial syndromes, short palate, or post-adenoidectomy.
Eligibility Criteria
Inclusion Criteria:
1. Children aged 4 to 12 years.
2. Non-syndromic cleft palate ± lip.
3. Confirmed diagnosis of velopharyngeal insufficiency due to cleft or non-cleft causes.
4. Cooperative children who are free from hearing, cognitive, and neuropsychiatric deficiencies.
5. Written informed consent from the parent/guardian and child assent where applicable.
Exclusion Criteria:
1. Previous secondary palatal speech surgery, including pharyngeal flap or sphincter pharyngoplasty.
2. Palatal fistula \>2 mm that may affect velopharyngeal gap measurements.
3. Acute upper respiratory infection.
4. Severe allergic rhinitis.
5. Severe uncontrolled laryngopharyngeal reflux.
6. Voice overuse or vocal abuse within the preceding 2 weeks.
7. Congenital or acquired laryngeal disease, including traumatic, inflammatory, neoplastic, or endocrinological disease.
\-
Source: ClinicalTrials.gov (NCT07832812). StuddyBuddy aggregates publicly available trial information.