- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07832812
Effect of Velopharyngeal Gap Size on Laryngeal Morphology and Vocal Function in Children With VPI
Effect of Velopharyngeal Gap Size on Laryngeal Morphology and Vocal Function in Children With Velopharyngeal Insufficiency
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.
Přehled studie
Postavení
Podmínky
Detailní popis
Although the primary communication problem in VPI is a resonance disorder, persistent velopharyngeal insufficiency may alter normal vocal behavior. To compensate for the loss of intraoral pressure, many children with VPI develop excessive laryngeal muscle tension, increased respiratory effort, abnormal vocal fold adduction, or other compensatory phonatory behaviors. Over time, this laryngeal hyperfunction and other compensatory behaviors may result in muscle tension dysphonia and cause morphological changes of the vocal folds, such as vocal nodules, inflammation, and edema.
The reported prevalence of voice disorders in VPI patients ranges widely, from 5.5% based on a retrospective parent-reported hoarseness questionnaire to 72% in a prospective study employing perceptual voice assessment. This wide disparity primarily reflects methodological differences-such as indirect parental report versus direct perceptual evaluation, retrospective versus prospective designs, and heterogeneous patient samples-that profoundly influence prevalence estimates. Individuals with VPI may exhibit chronic hoarseness, forced, soft, strangled, or aspirated phonation. Additionally, children with CP ± lip (L) often have higher F0, jitter, and shimmer in their voices compared to typically developing children. Aydinli et al. have also shown that children with CP ± L who use glottal stops as a compensatory articulation strategy tend to have higher F0, shimmer, and jitter, indicating increased tension in their vocal cords affecting vocal fold vibration. Vocal nodules were the most common anatomical finding among individuals with CP and CP/L.
The relationship between VPI severity and concomitant voice disorders has been the subject of abundant investigation, yet studies across all assessment modalities have yielded inconsistent results. At the subjective level, Deengam et al. reported a correlation between hypernasality severity and perceptual voice disorder ratings, whereas Fujiki and Thibeault found that children with severe hypernasal resonance were 78% less likely to present with laryngeal pathology. Further adding to the discrepancy, Hamming et al., using a history of speech surgery as an indicator for VPI severity in a retrospective design, found no significant association between VPI and hoarseness, suggesting that voice abnormalities may persist independently of severity.
In an effort to resolve these inconsistencies, objective instrumental techniques-particularly nasoendoscopy-have been employed for precise VPI severity evaluation. However, reliance on the velopharyngeal closure pattern alone (e.g., closing, inconsistent, open) has not clarified the picture: D'Antonio et al. found no relationship between laryngeal/voice findings and velopharyngeal function, while McWilliams et al. reported that children with a borderline closure mechanism were more susceptible to voice changes. These persistent vocal abnormalities likely reflect chronic compensatory behaviors and laryngeal tissue changes driven by the pre-repair aerodynamic deficit, meaning a dynamic closure pattern does not reliably capture the cumulative vocal load imposed by the condition.
A more direct anatomical metric-the velopharyngeal gap (VPG) size-should theoretically be a better predictor. Yet here too, findings diverge: Lehes et al. observed no significant association between VPI severity and acoustic voice parameters, implying that increasing gap size does not necessarily correlate with voice quality, while Villafuerte-Gonzalez et al. reported abnormal acoustic measures, including elevated shimmer, specifically in cases with moderate VPG. Critically, both VPG size studies were limited by extremely small sample sizes (≤18 patients), severely constraining generalizability and statistical power. Thus, the contradictory evidence across subjective and objective measures-including the most direct anatomical index-underscores a fundamental gap in the literature and highlights the urgent need for a large-scale, adequately powered investigation that systematically quantifies velopharyngeal gap size via nasoendoscopy and rigorously examines its correlation with both subjective and objective voice outcomes.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Aya A Abdulmonem, Resident
- Telefonní číslo: +201012667957
- E-mail: aya.atef693@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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).
Popis
Inclusion Criteria:
- 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.
- Written informed consent from the parent/guardian and child assent where applicable.
Exclusion Criteria:
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Previous secondary palatal speech surgery, including pharyngeal flap or sphincter pharyngoplasty.
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Palatal fistula >2 mm that may affect velopharyngeal gap measurements.
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Acute upper respiratory infection.
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Severe allergic rhinitis.
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Severe uncontrolled laryngopharyngeal reflux.
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Voice overuse or vocal abuse within the preceding 2 weeks.
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Congenital or acquired laryngeal disease, including traumatic, inflammatory, neoplastic, or endocrinological disease.
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Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
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Small/near complete VP gap
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Moderate VP gap
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Large VP gap
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Age and sex matched control group
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Subjective measurements of severity of dysphonia
Časové okno: At baseline assessment
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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). |
At baseline assessment
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Subjective measurements of patient's assessment of voice impairment severity
Časové okno: At baseline assessment
|
Measurements of scores of Arabic pediatric voice handicap index (APVHI) Minimum value: Zero , Maximum value: 92 Higher scores means worse outcomes |
At baseline assessment
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Subjective measurements of adequacy of velopharyngeal port
Časové okno: At baseline assessment
|
Number of participants with hypernasality and nasal air emission by simple clinical tests (Gutzman a/i test and Crezmerk cold mirror test) |
At baseline assessment
|
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Objective measurements of velopharyngeal gap quantification
Časové okno: At baseline assessment
|
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 |
At baseline assessment
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Objective measurement of elements of hyperfunction
Časové okno: At baseline assessment
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Number of participants with anteroposterior and lateral pharyngeal compression, number of participants with vocal fold nodules, number of participants with edema or mucosal thickening by videostroboscopic examination There is no definite score, we will only detect the number of patients with these findings There are no multiple assessments with different units of measure |
At baseline assessment
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Objective measurements of vocal pitch
Časové okno: At baseline assessment
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Measurements of acoustic analysis: Fundamental frequency (Hz) |
At baseline assessment
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Objective measurements of vocal waveform frequency aperiodicity
Časové okno: At baseline assessment
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Measurements of acoustic analysis: Jitter (%) |
At baseline assessment
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Objective measurements of vocal waveform amplitude aperiodicity
Časové okno: At baseline assessment
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Measurements of acoustic analysis: Shimmer (dB) |
At baseline assessment
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Objective measurements of vocal waveform periodicity to aperiodicity ratio
Časové okno: At baseline assessment
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Measurements of acoustic analysis: Harmonic to noise ratio (dB) |
At baseline assessment
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Objective measurements of laryngeal function and glottal insufficiency
Časové okno: At baseline assessment
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Measurements of aerodynamic parameter: Maximum phonation time (seconds) |
At baseline assessment
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Essam M Aref, Prof, Phoniatrics Department, Assiut University Hospital
- Studijní židle: Nada A Kamel, Lecturer, Phoniatrics Department, Assiut University Hospital
Publikace a užitečné odkazy
Obecné publikace
- Golding-Kushner KJ, Argamaso RV, Cotton RT, Grames LM, Henningsson G, Jones DL, Karnell MP, Klaiman PG, Lewin ML, Marsh JL, et al. Standardization for the reporting of nasopharyngoscopy and multiview videofluoroscopy: a report from an International Working Group. Cleft Palate J. 1990 Oct;27(4):337-47; discussion 347-8. doi: 10.1597/1545-1569(1990)0272.3.co;2.
- Deengam N, Prathanee B, Laohakittikul C. Prevalence of Voice Disorders and Correlation Between Hypernasality and Acoustic Characteristics in Children With Cleft Lip and Palate. Laryngoscope Investig Otolaryngol. 2025 May 22;10(3):e70165. doi: 10.1002/lio2.70165. eCollection 2025 Jun.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AU-VPI-2026-01
Informace o lécích a zařízeních, studijní dokumenty
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