About this trial
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
This trial accepts healthy volunteersQualifiers
Children aged 4 to 12 years.
Non-syndromic cleft palate ± lip.
Confirmed diagnosis of velopharyngeal insufficiency due to cleft or non-cleft causes.
Cooperative children who are free from hearing, cognitive, and neuropsychiatric deficiencies.
Disqualifiers
Previous secondary palatal speech surgery, including pharyngeal flap or sphincter pharyngoplasty.
Palatal fistula >2 mm that may affect velopharyngeal gap measurements.
Acute upper respiratory infection.
Severe allergic rhinitis.
Trial population
Children aged 4-12 years with confirmed velopharyngeal insufficiency (VPI) will be consecutively recruited from the Phoniatric Unit, ENT Department, Assiut University Hospital. Participants will include children with non-syndromic cleft palate with or without cleft lip and children with VPI due to other cleft or non-cleft causes. Participants will be classified according to velopharyngeal gap size into small/near-complete, moderate, and large gap groups (23 children per group). An age- and sex-matched control group of 23 children without VPI or voice disorders will also be included (total planned sample: 92).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Subjective measurements of severity of dysphonia
Measurements of vocal characteristics by a modified GRBAS scale, with 4 grades from 0 (normal) to 3 (severe dysphonia) known as GSLBI =overall grade (G), strained (S), leaky (L), breathy (B), and irregular (I).
Subjective measurements of patient's assessment of voice impairment severity
Measurements of scores of Arabic pediatric voice handicap index (APVHI) Minimum value: Zero , Maximum value: 92 Higher scores means worse outcomes
Subjective measurements of adequacy of velopharyngeal port
Number of participants with hypernasality and nasal air emission by simple clinical tests (Gutzman a/i test and Crezmerk cold mirror test)
Objective measurements of velopharyngeal gap quantification
Measurements of velopharygeal gap size as a relative ratio of the persistent open area (in pixels) during maximum phonation divided by the total available portal area at rest (in pixels) with the aid of ImageJ software (version 1.52a, National Institutes of Health, USA) by using flexible nasofiberoscopy
Locations
Sponsors and contacts
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