Velopharyngeal InsufficiencyNCT07832812
Effect of Velopharyngeal Gap Size on Laryngeal Morphology and Vocal Function in Children With VPI
An observational study of Velopharyngeal Insufficiency, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Velopharyngeal Insufficiency
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2026to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- 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.
Who cannot join
- 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.
- Severe uncontrolled laryngopharyngeal reflux.
- Voice overuse or vocal abuse within the preceding 2 weeks.
- Congenital or acquired laryngeal disease, including traumatic, inflammatory, neoplastic, or endocrinological disease.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Velopharyngeal Insufficiency
- Keywords
- Velopharyngeal Insufficiency, Velopharyngeal gap, laryngeal pathology, pediatric voice disorders
- Medical subject headings
- Velopharyngeal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Small/near complete VP gap | Not described | |
| Moderate VP gap | Not described | |
| Large VP gap | Not described | |
| Age and sex matched control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline assessment
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
Measured: At baseline assessment
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)
Measured: At baseline assessment
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
Measured: At baseline assessment
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
Measured: At baseline assessment
Objective measurements of vocal pitch
Measurements of acoustic analysis: Fundamental frequency (Hz)
Measured: At baseline assessment
Objective measurements of vocal waveform frequency aperiodicity
Measurements of acoustic analysis: Jitter (%)
Measured: At baseline assessment
Objective measurements of vocal waveform amplitude aperiodicity
Measurements of acoustic analysis: Shimmer (dB)
Measured: At baseline assessment
Objective measurements of vocal waveform periodicity to aperiodicity ratio
Measurements of acoustic analysis: Harmonic to noise ratio (dB)
Measured: At baseline assessment
Objective measurements of laryngeal function and glottal insufficiency
Measurements of aerodynamic parameter: Maximum phonation time (seconds)
Measured: At baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start25 Sep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Velopharyngeal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Atef Abdul-monem, Assiut University
- Investigators
- Essam M Aref, Prof, Study chair, Phoniatrics Department, Assiut University HospitalNada A Kamel, Lecturer, Study chair, Phoniatrics Department, Assiut University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832812
- Sponsor's protocol ID
- AU-VPI-2026-01
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 2253379Deengam 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Velopharyngeal Gap Size on Laryngeal Morphology and Vocal Function in Children With Velopharyngeal Insufficiency
- ClinicalTrials.gov ID
- NCT07832812
- Acronym / sponsor ID
- AU-VPI-2026-01
- Conditions
- Velopharyngeal Insufficiency
- Keywords
- Velopharyngeal Insufficiency, Velopharyngeal gap, laryngeal pathology, pediatric voice disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Small/near complete VP gap | – | – |
| Moderate VP gap | – | – |
| Large VP gap | – | – |
| Age and sex matched control group | – | – |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- Severe uncontrolled laryngopharyngeal reflux.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective measurements of severity of dysphonia
Time frame: 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).
Subjective measurements of patient's assessment of voice impairment severity
Time frame: At baseline assessment
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
Time frame: 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)
Objective measurements of velopharyngeal gap quantification
Time frame: 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
Objective measurement of elements of hyperfunction
Time frame: 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
Objective measurements of vocal pitch
Time frame: At baseline assessment
Measurements of acoustic analysis: Fundamental frequency (Hz)
Objective measurements of vocal waveform frequency aperiodicity
Time frame: At baseline assessment
Measurements of acoustic analysis: Jitter (%)
Objective measurements of vocal waveform amplitude aperiodicity
Time frame: At baseline assessment
Measurements of acoustic analysis: Shimmer (dB)
Objective measurements of vocal waveform periodicity to aperiodicity ratio
Time frame: At baseline assessment
Measurements of acoustic analysis: Harmonic to noise ratio (dB)
Objective measurements of laryngeal function and glottal insufficiency
Time frame: At baseline assessment
Measurements of aerodynamic parameter: Maximum phonation time (seconds)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 2253379Golding-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.
- Background: PubMed 40405897Deengam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Essam M Aref, Prof study chair
Phoniatrics Department, Assiut University Hospital
Nada A Kamel, Lecturer study chair
Phoniatrics Department, Assiut University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Velopharyngeal Insufficiency, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya A Abdulmonem, Resident (+201012667957, aya.atef693@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective measurements of severity of dysphonia (time frame: At baseline assessment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07832812, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.