ClinicalTrials.gg
Not yet recruitingNCT07832812Updated Sep 24, 2026

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

An observational study in Velopharyngeal Insufficiency, sponsored by Assiut University. Not yet recruiting. Open to participants aged 4 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
92
Ages
4 Years to 12 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Velopharyngeal Insufficiency

Keywords

  • Velopharyngeal Insufficiency
  • Velopharyngeal gap
  • laryngeal pathology
  • pediatric voice disorders
03

In context

Velopharyngeal Insufficiency

20 studies on the registry are indexed under Velopharyngeal Insufficiency; 9 are open to participants now.

Browse Velopharyngeal Insufficiency studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study 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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 from the parent/guardian and child assent where applicable.

Exclusion criteria

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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Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

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05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
92 participants (estimated)
Patient registry
No

Groups and cohorts

  • Small/near complete VP gap
  • Moderate VP gap
  • Large VP gap
  • Age and sex matched control group
06

What researchers measure

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

  5. Objective measurement of elements of hyperfunction

    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

    Time frame: At baseline assessment

  6. Objective measurements of vocal pitch

    Measurements of acoustic analysis: Fundamental frequency (Hz)

    Time frame: At baseline assessment

  7. Objective measurements of vocal waveform frequency aperiodicity

    Measurements of acoustic analysis: Jitter (%)

    Time frame: At baseline assessment

  8. Objective measurements of vocal waveform amplitude aperiodicity

    Measurements of acoustic analysis: Shimmer (dB)

    Time frame: At baseline assessment

  9. Objective measurements of vocal waveform periodicity to aperiodicity ratio

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

    Time frame: At baseline assessment

  10. Objective measurements of laryngeal function and glottal insufficiency

    Measurements of aerodynamic parameter: Maximum phonation time (seconds)

    Time frame: At baseline assessment

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 2253379 ↗
  • 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. PubMed 40405897 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07832812
Lead sponsor
Assiut University
Responsible party
Aya Atef Abdul-monem (Assistant lecturer, Assiut University) — Principal investigator
First posted
Sep 22, 2026
Start date
Sep 25, 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2028 (estimated)
Last update
Sep 24, 2026

Study contacts

Aya A Abdulmonem, Resident
Contact
aya.atef693@gmail.com
+201012667957
Essam M Aref, Prof
study chair · Phoniatrics Department, Assiut University Hospital
Nada A Kamel, Lecturer
study chair · Phoniatrics Department, Assiut University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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