Velopharyngeal InsufficiencyNCT07264036
Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study
A study testing Pharyngeal Wall Augmentation Injection in people with Velopharyngeal Insufficiency and Head and Neck Cancer, run by Vanessa Torrecillas at 1 site in United States.
Trial summary
Some head and neck cancer survivors develop velopharyngeal dysfunction (VPD), a problem with closure between the soft palate and throat that can cause nasal-sounding speech, food or liquid leaking into the nose, difficulty swallowing, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Velopharyngeal Insufficiency, Head and Neck Cancer, Survivorship
- What is being tested?
- Pharyngeal Wall Augmentation Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 1 Jul 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking adults (≥18 years) History of head and neck cancer treated with surgical resection, chemoradiation, or both Presence of perceptual hypernasality on clinical assessment
Who cannot join
- Pre-existing or suspected non-cancer-related causes of velopharyngeal dysfunction Contraindications to pharyngeal wall augmentation Requirement for more intensive active cancer surveillance Planned future surgical or medical treatments to the pharynx that would interfere with participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Vanessa Torrecillas, MD, 4349242040, vge3bm@uvahealth.org
Elena Squire, MPH, 434-243-3607, EM8KZ@uvahealth.org
About this study
Official title: Injectable Augmentation Outcomes in Post-Radiation Head and Neck Cancer Patients With Velopharyngeal Dysfunction
Some head and neck cancer survivors develop velopharyngeal dysfunction (VPD), a problem with closure between the soft palate and throat that can cause nasal-sounding speech, food or liquid leaking into the nose, difficulty swallowing, and reduced quality of life. This study aims to better understand VPD in this population and to evaluate whether pharyngeal wall augmentation (plumping up the back wall of the throat) can improve speech and swallowing.
Participants will undergo a multidisciplinary assessment including physical examination, flexible nasolaryngoscopy, speech recording and acoustic analysis, nasometry, clinical swallowing evaluation, and fiberoptic endoscopic evaluation of swallowing (FEES).
Read more
Aim 1: Determine the prevalence, severity, and functional impact of VPD in head and neck cancer survivors.
Aim 2: Assess the feasibility and usefulness of advanced diagnostic tools for VPD.
The investigators hypothesize that high nasalance scores (>1 SD above normal) will accurately predict VPD with at least 75% positive predictive value and will correlate with worse communication-related quality of life (CPIB).
The investigators also hypothesize that participants with VPD will have more pharyngeal residue or nasal regurgitation on FEES, and that these findings will be associated with lower swallowing-related quality of life (SWAL-QOL).
Aim 3: Evaluate the effectiveness of pharyngeal wall augmentation injections for improving speech intelligibility and swallowing function.
The investigators expect that this treatment will lead to measurable changes in both objective assessments and patient-reported outcomes. The results will help improve diagnosis and management of VPD in head and neck cancer survivors.
Read the detailed description
Velopharyngeal dysfunction (VPD) is a disorder in which the soft palate and posterior pharyngeal wall do not close adequately during speech and swallowing. Head and neck cancer (HNC) survivors may develop VPD as a result of neuromuscular impairment from surgical resection and/or radiation therapy. Consequences include hypernasal speech from nasal air escape, nasopharyngeal residue during swallowing, nasal regurgitation, and reductions in speech and swallowing-related quality of life. Despite its clinical relevance, VPD in HNC survivors is under-recognized, and evidence regarding optimal diagnostic methods and effective interventions remains limited. This study aims to characterize VPD in this population, evaluate the diagnostic utility of advanced assessment tools, and assess the therapeutic effect of pharyngeal wall augmentation.
Overview This is a prospective study using a multidisciplinary, multimodal assessment protocol to evaluate speech and swallowing function in HNC survivors with suspected or confirmed VPD. Participants will undergo standardized clinical, instrumental, and patient-reported outcome assessments. A subset of participants with confirmed VPD will receive pharyngeal wall augmentation as part of standard clinical care, allowing for pre- and post-intervention comparison.
Aim 1: Characterization of VPD in HNC Survivors
Describe the prevalence, severity, and functional impact of VPD in this population. Participants will complete a comprehensive evaluation including:
Oropharyngeal physical examination to identify structural or neuromuscular contributors to impaired velopharyngeal closure.
Flexible nasolaryngoscopy to assess closure patterns during speech and swallowing tasks.
Acoustic speech analysis and objective measures of speech intelligibility.
Nasometry to quantify nasalance and the degree of hypernasality.
Clinical swallowing evaluation, documenting perceptual indicators of safety and efficiency.
Fiberoptic Endoscopic Evaluation of Swallowing (FEES) to visualize bolus flow, pharyngeal residue, and nasal regurgitation.
Patient-reported outcomes will include the Speech Handicap Index (SHI) and the Swallowing Quality of Life Questionnaire (SWAL-QOL). These measures will characterize functional limitations associated with VPD.
Aim 2: Feasibility and Utility of Advanced Diagnostic Tools Aim 2a: Nasometry as a Diagnostic Indicator This component evaluates whether nasalance scores can reliably identify VPD. The primary hypothesis is that nasalance values >1 standard deviation above normative means will demonstrate a positive predictive value ≥75% when compared with endoscopic confirmation. Correlations will be assessed between nasalance and SHI scores to determine whether acoustic measures reflect patient-perceived communication limitations.
Aim 2b: FEES Indicators of VPD and Functional Correlates
This component assesses whether swallowing abnormalities on FEES are associated with VPD. Participants with confirmed VPD are expected to exhibit:
increased pharyngeal residue, and/or nasal regurgitation during bolus presentation.
These findings will be correlated with SWAL-QOL scores to determine whether FEES characteristics reflect functional swallowing impairment. Results may support FEES as a useful adjunctive tool in evaluating the impact of VPD on swallowing physiology.
Aim 3: Efficacy of Pharyngeal Wall Augmentation Participants with confirmed VPD who are clinically indicated for treatment will undergo pharyngeal wall augmentation using standard-of-care techniques. Injection material and volume will be determined by treating clinicians. The intervention is intended to reduce the velopharyngeal gap and improve closure during speech and swallowing.
Outcome Measures
Pre- and post-intervention comparisons will include:
Nasalance scores Acoustic speech parameters and overall intelligibility Perceptual ratings of speech resonance FEES findings (pharyngeal residue, nasal regurgitation) Patient-reported outcomes (SHI, SWAL-QOL) Participant-reported impressions of change
The primary hypothesis is that pharyngeal wall augmentation will result in measurable improvement in both objective assessments and patient-reported function.
Significance
This study will provide:
A comprehensive description of VPD in HNC survivors. Evidence on the diagnostic value of nasometry and FEES for identifying clinically meaningful VPD.
Prospective data on the functional impact of pharyngeal wall augmentation. Findings will inform best practices for the diagnosis and management of VPD in HNC survivors and support the development of multidisciplinary clinical pathways for improving communication and swallowing outcomes.
- Conditions
- Velopharyngeal Insufficiency, Head and Neck Cancer, Survivorship, Dysphagia, Speech Disorder
- Being tested
- Pharyngeal Wall Augmentation Injection
- Keywords
- velopharyngeal dysfunction, hypernasal speech, pharyngeal wall augmentation, nasometry, head and neck cancer, survivorship
- Medical subject headings
- Velopharyngeal Insufficiency, Head and Neck Neoplasms, Deglutition Disorders, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal Wall Augmentation InjectionProcedure or surgery
Participants with confirmed velopharyngeal dysfunction (VPD) who meet clinical criteria may elect to receive a pharyngeal wall augmentation injection. The procedure involves the submucosal injection of a biocompatible material into the posterior pharyngeal wall to improve velopharyngeal closure during speech and swallowing. Injection volume and technique will be determined by the treating clinician based on individual anatomy and functional assessment. All participants will undergo standardized assessments of speech intelligibility, nasalance, swallowing function, and patient-reported outcomes before and after the procedure.
Timing:
The procedure will occur once at the clinically indicated visit. Post-procedure assessments will be conducted at standardized follow-up intervals to evaluate functional outcomes
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic with Possible Injection Augmentation | Experimental | All participants will undergo a standardized, multidisciplinary evaluation including physical examination, flexible nasolaryngoscopy, acoustic speech analysis, nasometry, clinical swallowing assessment, and fiberoptic endoscopic evaluation of swallowing (FEES). A subset of participants with confirmed velopharyngeal dysfunction (VPD) who meet clinical criteria may elect to receive a pharyngeal wall augmentation injection as part of standard-of-care treatment. All participants, regardless of whether they receive the injection, will have pre-assessment data collected to evaluate speech intelligibility, nasalance, swallowing function, and patient-reported outcomes. The patients who undergo the pharyngeal augmentation injection will also have post-assessment data collected. No formal comparison between participants who do and do not receive the injection will be performed; all data will be analyzed individually. Receives: Procedure: Pharyngeal Wall Augmentation Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Nasometry and FEES for Characterizing Velopharyngeal Dysfunction
Feasibility will be reported as the percentage of enrolled participants with complete, usable nasometry and FEES data at baseline. Data quality will be defined by the proportion of recordings meeting predefined technical standards for interpretation. Additional exploratory analyses will examine correlations between nasometry and FEES findings and clinical reference standards (perceptual speech ratings, SHI and SWAL-QOL scores), but correlation statistics will not be used as outcome units for feasibility reporting.
Measured: Baseline Assessment
Secondary outcomes (5)
Accuracy of Nasometry for Identifying VPD
Proportion of participants with elevated nasalance scores (>1 SD above normative mean) who also demonstrate VPD on flexible nasopharyngoscopy as determined by skilled rater.
Measured: Baseline
Nasometry Characterization of Velopharyngeal Dysfunction
Nasalance will be quantified using nasometry (percent resonance score). Higher values indicate greater hypernasality.
Measured: Baseline, 6 weeks post injection
Modified FEES Observation of Pharyngeal Residue and Nasal Regurgitation
Proportion of participants demonstrating residue or nasal regurgitation on modified FEES exam.
Measured: Baseline, 6 weeks post injection
Patient-Reported Communication Function
Change in total Speech Handicap Index (SHI) score
Measured: Baseline, 6 weeks post injection, 6 months post injection
Change in Patient Reported Swallowing-Related Quality of Life
SWAL-QOL total score
Measured: Baseline, 6 months post injection, 6 months post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start24 Mar 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Velopharyngeal InsufficiencyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanessa Torrecillas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vanessa Torrecillas, University of Virginia
- Investigators
- Vanessa Torrecillas, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264036
- Sponsor's protocol ID
- PJ05069
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study results will be published in peer-reviewed journals. Individual participant-level data will not be made publicly available. Only aggregate data and summary findings will be shared.
Publications
Youssof S, Romero-Clark C, Warner T, Plowman E. Dysphagia-related quality of life in oculopharyngeal muscular dystrophy: Psychometric properties of the SWAL-QOL instrument. Muscle Nerve. 2017 Jul;56(1):28-35. doi: 10.1002/mus.25441. Epub 2017 Feb 12.
PubMed 27759888Starmer HM, Tippett DC, Webster KT. Effects of laryngeal cancer on voice and swallowing. Otolaryngol Clin North Am. 2008 Aug;41(4):793-818, vii. doi: 10.1016/j.otc.2008.01.018.
PubMed 18570960Neubauer PD, Rademaker AW, Leder SB. The Yale Pharyngeal Residue Severity Rating Scale: An Anatomically Defined and Image-Based Tool. Dysphagia. 2015 Oct;30(5):521-8. doi: 10.1007/s00455-015-9631-4. Epub 2015 Jun 7.
PubMed 26050238Kummer, A. W. (2014). Evaluation and treatment of resonance disorders. Language, Speech, and Hearing Services in Schools, 45(3), 183-195. https://doi.org/10.1044/2014_LSHSS-14-0036
Karnell, M. P., Christensen, A. J., & Rosenthal, E. L. (2007). Quality of life outcomes in head and neck cancer patients post-treatment. Otolaryngology-Head and Neck Surgery, 136(5), 698-703. https://doi.org/10.1016/j.otohns.2007.01.039
Kallambettu V, Bae Y, Carrau R. Velopharyngeal Function Post Head and Neck Cancer: A Review. Ear Nose Throat J. 2024 Sep;103(9):NP567-NP577. doi: 10.1177/01455613211070895. Epub 2022 Jan 28.
PubMed 35081810Golding-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 2253379Alfwaress F, Kummer AW, Weinrich B. Nasalance Scores for Normal Speakers of American English Obtained by the Nasometer II Using the MacKay-Kummer SNAP-R Test. Cleft Palate Craniofac J. 2022 Jun;59(6):765-773. doi: 10.1177/10556656211025406. Epub 2021 Jun 29.
PubMed 34184583
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injectable Augmentation Outcomes in Post-Radiation Head and Neck Cancer Patients With Velopharyngeal Dysfunction
- ClinicalTrials.gov ID
- NCT07264036
- Acronym / sponsor ID
- PJ05069
- Conditions
- Velopharyngeal Insufficiency, Head and Neck Cancer, Survivorship, Dysphagia, Speech Disorder
- Keywords
- velopharyngeal dysfunction, hypernasal speech, pharyngeal wall augmentation, nasometry, head and neck cancer, survivorship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vanessa TorrecillasUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 4 Dec 2025 (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.
Some head and neck cancer survivors develop velopharyngeal dysfunction (VPD), a problem with closure between the soft palate and throat that can cause nasal-sounding speech, food or liquid leaking into the nose, difficulty swallowing, and reduced quality of life. This study aims to better understand VPD in this population and to evaluate whether pharyngeal wall augmentation (plumping up the back wall of the throat) can improve speech and swallowing.
Participants will undergo a multidisciplinary assessment including physical examination, flexible nasolaryngoscopy, speech recording and acoustic analysis, nasometry, clinical swallowing evaluation, and fiberoptic endoscopic evaluation of swallowing (FEES).
Aim 1: Determine the prevalence, severity, and functional impact of VPD in head and neck cancer survivors.
Aim 2: Assess the feasibility and usefulness of advanced diagnostic tools for VPD.
The investigators hypothesize that high nasalance scores (>1 SD above normal) will accurately predict VPD with at least 75% positive predictive value and will correlate with worse communication-related quality of life (CPIB).
The investigators also hypothesize that participants with VPD will have more pharyngeal residue or nasal regurgitation on FEES, and that these findings will be associated with lower swallowing-related quality of life (SWAL-QOL).
Aim 3: Evaluate the effectiveness of pharyngeal wall augmentation injections for improving speech intelligibility and swallowing function.
The investigators expect that this treatment will lead to measurable changes in both objective assessments and patient-reported outcomes. The results will help improve diagnosis and management of VPD in head and neck cancer survivors.
Detailed description
Velopharyngeal dysfunction (VPD) is a disorder in which the soft palate and posterior pharyngeal wall do not close adequately during speech and swallowing. Head and neck cancer (HNC) survivors may develop VPD as a result of neuromuscular impairment from surgical resection and/or radiation therapy. Consequences include hypernasal speech from nasal air escape, nasopharyngeal residue during swallowing, nasal regurgitation, and reductions in speech and swallowing-related quality of life. Despite its clinical relevance, VPD in HNC survivors is under-recognized, and evidence regarding optimal diagnostic methods and effective interventions remains limited. This study aims to characterize VPD in this population, evaluate the diagnostic utility of advanced assessment tools, and assess the therapeutic effect of pharyngeal wall augmentation.
Overview This is a prospective study using a multidisciplinary, multimodal assessment protocol to evaluate speech and swallowing function in HNC survivors with suspected or confirmed VPD. Participants will undergo standardized clinical, instrumental, and patient-reported outcome assessments. A subset of participants with confirmed VPD will receive pharyngeal wall augmentation as part of standard clinical care, allowing for pre- and post-intervention comparison.
Aim 1: Characterization of VPD in HNC Survivors
Describe the prevalence, severity, and functional impact of VPD in this population. Participants will complete a comprehensive evaluation including:
Oropharyngeal physical examination to identify structural or neuromuscular contributors to impaired velopharyngeal closure.
Flexible nasolaryngoscopy to assess closure patterns during speech and swallowing tasks.
Acoustic speech analysis and objective measures of speech intelligibility.
Nasometry to quantify nasalance and the degree of hypernasality.
Clinical swallowing evaluation, documenting perceptual indicators of safety and efficiency.
Fiberoptic Endoscopic Evaluation of Swallowing (FEES) to visualize bolus flow, pharyngeal residue, and nasal regurgitation.
Patient-reported outcomes will include the Speech Handicap Index (SHI) and the Swallowing Quality of Life Questionnaire (SWAL-QOL). These measures will characterize functional limitations associated with VPD.
Aim 2: Feasibility and Utility of Advanced Diagnostic Tools Aim 2a: Nasometry as a Diagnostic Indicator This component evaluates whether nasalance scores can reliably identify VPD. The primary hypothesis is that nasalance values >1 standard deviation above normative means will demonstrate a positive predictive value ≥75% when compared with endoscopic confirmation. Correlations will be assessed between nasalance and SHI scores to determine whether acoustic measures reflect patient-perceived communication limitations.
Aim 2b: FEES Indicators of VPD and Functional Correlates
This component assesses whether swallowing abnormalities on FEES are associated with VPD. Participants with confirmed VPD are expected to exhibit:
increased pharyngeal residue, and/or nasal regurgitation during bolus presentation.
These findings will be correlated with SWAL-QOL scores to determine whether FEES characteristics reflect functional swallowing impairment. Results may support FEES as a useful adjunctive tool in evaluating the impact of VPD on swallowing physiology.
Aim 3: Efficacy of Pharyngeal Wall Augmentation Participants with confirmed VPD who are clinically indicated for treatment will undergo pharyngeal wall augmentation using standard-of-care techniques. Injection material and volume will be determined by treating clinicians. The intervention is intended to reduce the velopharyngeal gap and improve closure during speech and swallowing.
Outcome Measures
Pre- and post-intervention comparisons will include:
Nasalance scores Acoustic speech parameters and overall intelligibility Perceptual ratings of speech resonance FEES findings (pharyngeal residue, nasal regurgitation) Patient-reported outcomes (SHI, SWAL-QOL) Participant-reported impressions of change
The primary hypothesis is that pharyngeal wall augmentation will result in measurable improvement in both objective assessments and patient-reported function.
Significance
This study will provide:
A comprehensive description of VPD in HNC survivors. Evidence on the diagnostic value of nasometry and FEES for identifying clinically meaningful VPD.
Prospective data on the functional impact of pharyngeal wall augmentation. Findings will inform best practices for the diagnosis and management of VPD in HNC survivors and support the development of multidisciplinary clinical pathways for improving communication and swallowing outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic with Possible Injection Augmentation | Experimental | Procedure: Pharyngeal Wall Augmentation InjectionAll participants will undergo a standardized, multidisciplinary evaluation including physical examination, flexible nasolaryngoscopy, acoustic speech analysis, nasometry, clinical swallowing assessment, and fiberoptic endoscopic evaluation of swallowing (FEES). A subset of participants with confirmed velopharyngeal dysfunction (VPD) who meet clinical criteria may elect to receive a pharyngeal wall augmentation injection as part of standard-of-care treatment. All participants, regardless of whether they receive the injection, will have pre-assessment data collected to evaluate speech intelligibility, nasalance, swallowing function, and patient-reported outcomes. The patients who undergo the pharyngeal augmentation injection will also have post-assessment data collected. No formal comparison between participants who do and do not receive the injection will be performed; all data will be analyzed individually. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking adults (≥18 years) History of head and neck cancer treated with surgical resection, chemoradiation, or both Presence of perceptual hypernasality on clinical assessment
Key exclusion criteria (1 listed)
- Pre-existing or suspected non-cancer-related causes of velopharyngeal dysfunction Contraindications to pharyngeal wall augmentation Requirement for more intensive active cancer surveillance Planned future surgical or medical treatments to the pharynx that would interfere with participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharyngeal Wall Augmentation InjectionParticipants with confirmed velopharyngeal dysfunction (VPD) who meet clinical criteria may elect to receive a pharyngeal wall augmentation injection. The procedure involves the submucosal injection of a biocompatible material into the posterior pharyngeal wall to improve velopharyngeal closure during speech and swallowing. Injection volume and technique will be determined by the treating clinician based on individual anatomy and functional assessment. All participants will undergo standardized assessments of speech intelligibility, nasalance, swallowing function, and patient-reported outcomes before and after the procedure. Timing: The procedure will occur once at the clinically indicated visit. Post-procedure assessments will be conducted at standardized follow-up intervals to evaluate functional outcomes | Procedure or surgery | Diagnostic with Possible Injection Augmentation |
Primary outcome
Feasibility of Nasometry and FEES for Characterizing Velopharyngeal Dysfunction
Time frame: Baseline Assessment
Feasibility will be reported as the percentage of enrolled participants with complete, usable nasometry and FEES data at baseline. Data quality will be defined by the proportion of recordings meeting predefined technical standards for interpretation. Additional exploratory analyses will examine correlations between nasometry and FEES findings and clinical reference standards (perceptual speech ratings, SHI and SWAL-QOL scores), but correlation statistics will not be used as outcome units for feasibility reporting.
5 secondary outcomes
Accuracy of Nasometry for Identifying VPD
Time frame: Baseline
Nasometry Characterization of Velopharyngeal Dysfunction
Time frame: Baseline, 6 weeks post injection
Modified FEES Observation of Pharyngeal Residue and Nasal Regurgitation
Time frame: Baseline, 6 weeks post injection
Patient-Reported Communication Function
Time frame: Baseline, 6 weeks post injection, 6 months post injection
Change in Patient Reported Swallowing-Related Quality of Life
Time frame: Baseline, 6 months post injection, 6 months post injection
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 28 Apr 2026.
- Background: PubMed 27759888Youssof S, Romero-Clark C, Warner T, Plowman E. Dysphagia-related quality of life in oculopharyngeal muscular dystrophy: Psychometric properties of the SWAL-QOL instrument. Muscle Nerve. 2017 Jul;56(1):28-35. doi: 10.1002/mus.25441. Epub 2017 Feb 12.
- Background: PubMed 18570960Starmer HM, Tippett DC, Webster KT. Effects of laryngeal cancer on voice and swallowing. Otolaryngol Clin North Am. 2008 Aug;41(4):793-818, vii. doi: 10.1016/j.otc.2008.01.018.
- Background: PubMed 26050238Neubauer PD, Rademaker AW, Leder SB. The Yale Pharyngeal Residue Severity Rating Scale: An Anatomically Defined and Image-Based Tool. Dysphagia. 2015 Oct;30(5):521-8. doi: 10.1007/s00455-015-9631-4. Epub 2015 Jun 7.
- BackgroundKummer, A. W. (2014). Evaluation and treatment of resonance disorders. Language, Speech, and Hearing Services in Schools, 45(3), 183-195. https://doi.org/10.1044/2014_LSHSS-14-0036
- BackgroundKarnell, M. P., Christensen, A. J., & Rosenthal, E. L. (2007). Quality of life outcomes in head and neck cancer patients post-treatment. Otolaryngology-Head and Neck Surgery, 136(5), 698-703. https://doi.org/10.1016/j.otohns.2007.01.039
- Background: PubMed 35081810Kallambettu V, Bae Y, Carrau R. Velopharyngeal Function Post Head and Neck Cancer: A Review. Ear Nose Throat J. 2024 Sep;103(9):NP567-NP577. doi: 10.1177/01455613211070895. Epub 2022 Jan 28.
- 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 34184583Alfwaress F, Kummer AW, Weinrich B. Nasalance Scores for Normal Speakers of American English Obtained by the Nasometer II Using the MacKay-Kummer SNAP-R Test. Cleft Palate Craniofac J. 2022 Jun;59(6):765-773. doi: 10.1177/10556656211025406. Epub 2021 Jun 29.
- Individual participant dataSharing planned: No. Study results will be published in peer-reviewed journals. Individual participant-level data will not be made publicly available. Only aggregate data and summary findings will be shared.
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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.
Vanessa Torrecillas, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharyngeal Wall Augmentation Injection in people with Velopharyngeal Insufficiency and Head and Neck Cancer, run by Vanessa Torrecillas at 1 site in United States.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Vanesssa Torrecillas, MD (434-924-2040, vge3bm@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Nasometry and FEES for Characterizing Velopharyngeal Dysfunction (time frame: Baseline Assessment). 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 NCT07264036, which also lists 8 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 28 Apr 2026.