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

22 września 2026 zaktualizowane przez: Aya Atef Abdul-monem, Assiut University

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Szacowany)

92

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

4 lata do 12 lat (Dziecko)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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).

Opis

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.

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Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: COHORT
  • Perspektywy czasowe: PROSPECTIVE

Kohorty i interwencje

Grupa / Kohorta
Small/near complete VP gap
Moderate VP gap
Large VP gap
Age and sex matched control group

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Subjective measurements of severity of dysphonia
Ramy czasowe: At baseline assessment

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
Subjective measurements of patient's assessment of voice impairment severity
Ramy czasowe: 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
Subjective measurements of adequacy of velopharyngeal port
Ramy czasowe: 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
Objective measurements of velopharyngeal gap quantification
Ramy czasowe: 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
Objective measurement of elements of hyperfunction
Ramy czasowe: At baseline assessment

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
Objective measurements of vocal pitch
Ramy czasowe: At baseline assessment

Measurements of acoustic analysis: Fundamental frequency (Hz)

At baseline assessment
Objective measurements of vocal waveform frequency aperiodicity
Ramy czasowe: At baseline assessment

Measurements of acoustic analysis: Jitter (%)

At baseline assessment
Objective measurements of vocal waveform amplitude aperiodicity
Ramy czasowe: At baseline assessment

Measurements of acoustic analysis: Shimmer (dB)

At baseline assessment
Objective measurements of vocal waveform periodicity to aperiodicity ratio
Ramy czasowe: At baseline assessment

Measurements of acoustic analysis: Harmonic to noise ratio (dB)

At baseline assessment
Objective measurements of laryngeal function and glottal insufficiency
Ramy czasowe: At baseline assessment

Measurements of aerodynamic parameter: Maximum phonation time (seconds)

At baseline assessment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Krzesło do nauki: Essam M Aref, Prof, Phoniatrics Department, Assiut University Hospital
  • Krzesło do nauki: Nada A Kamel, Lecturer, Phoniatrics Department, Assiut University Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

25 września 2026

Zakończenie podstawowe (Szacowany)

1 września 2027

Ukończenie studiów (Szacowany)

1 września 2028

Daty rejestracji na studia

Pierwszy przesłany

16 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 września 2026

Pierwszy wysłany (Rzeczywisty)

22 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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