Effect of Velopharyngeal Gap Size on Laryngeal Morphology and Vocal Function in Children With VPI

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-12
SponsorAssiut University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

92 Participants
are grouped into 4 trial groups
Group A: Small/near complete VP gap
Group B: Moderate VP gap
Group C: Large VP gap
Group D: Age and sex matched control group

Trial outcomes

Primary outcomes

1

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).

Time frame
At baseline assessment
2

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

Time frame
At baseline assessment
3

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)

Time frame
At baseline assessment
4

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

Time frame
At baseline assessment

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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