The Yale Pharyngeal Residue Severity Rating Scale: An Anatomically Defined and Image-Based Tool.
Paul D Neubauer, Alfred W Rademaker, Steven B Leder
https://pubmed.ncbi.nlm.nih.gov/26050238/Actively Recruiting
Led by Vanessa Torrecillas · Updated on 2026-04-28
20
Participants Needed
1
Research Sites
25 weeks
Total Duration
Velopharyngeal dysfunction VPD is a condition where the soft palate and throat do not close properly during speech and swallowing, leading to nasal-sounding speech, difficulty swallowing, and lowered quality of life. This research focuses on head and neck cancer survivors who may develop VPD due to surgery or radiation therapy. It aims to understand how common and severe VPD is in this group, evaluate advanced tools to diagnose it, and study the effects of a treatment called pharyngeal wall augmentation. Participants will receive a thorough evaluation including physical exams, flexible nasolaryngoscopy to observe throat closure, speech recording and acoustic analysis, nasometry to measure nasal sound, clinical swallowing assessments, and fiberoptic endoscopic evaluation of swallowing FEES. Those with confirmed VPD and meeting clinical criteria may choose to have a pharyngeal wall augmentation injection, which involves injecting a material to improve throat closure. This treatment is given once, and participants will have follow-up assessments to measure changes in speech and swallowing. Throughout the study, all participants undergo detailed assessments of speech intelligibility, nasalance, swallowing function, and quality of life using patient-reported questionnaires. Those receiving the injection will have additional evaluations after treatment to compare results. Key outcomes include the usefulness of nasometry and FEES in diagnosing VPD and the impact of the injection on speech and swallowing. The study helps improve diagnosis and care for VPD in head and neck cancer survivors.
CONDITIONS
Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot Study
V
Vanesssa Torrecillas, MD
E
Elena Squire, MPH
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Vanessa Torrecillas
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Study Diagnostic and Assessment Approach | Current Clinical Diagnostic Pathway |
|---|---|---|
| What it is | A standardized diagnostic pathway in which adults with a history of treated head and neck cancer and confirmed velopharyngeal dysfunction undergo speech/nasality assessment, swallowing evaluation (FEES), nasometry, and when eligible, may receive a pharyngeal wall augmentation injection to potentially improve closure. These assessments are repeated after the intervention. | A typical clinical diagnostic workup in post–head and neck cancer patients includes structured perceptual assessment (speech, resonance, nasality), nasopharyngoscopic examination, instrumental swallowing studies (such as FEES or videofluoroscopy), and measurement of nasalance. Optional interventions (including pharyngeal wall augmentation or other surgical/medical options) may be considered based on findings. |
| Role in trial | Serves as both the diagnostic approach to assess VPD features and, for eligible participants, as a therapeutic step to evaluate functional improvement after pharyngeal wall injection. | Establishes the presence and severity of VPD, informs management decisions, and determines need for interventions such as surgical, non-surgical, or rehabilitative approaches. |
| Primary use | To characterize VPD, measure nasalance, assess swallowing, and understand patient-reported outcomes before and after optional pharyngeal wall injection. | To diagnose and grade VPD, evaluate risks to swallowing and communication, and guide choices for management and intervention. |
| How it is given or performed | Initial assessment includes structured perceptual evaluation by a clinician, nasometry, and FEES. Eligible participants may then undergo a single submucosal pharyngeal wall augmentation injection. Follow-up diagnostic assessments repeat the initial measurements at defined intervals after injection. | Perceptual speech evaluation by a trained speech–language pathologist, direct visual or endoscopic inspection (typically nasopharyngoscopy), and instrumental swallowing studies are commonly performed. Nasometry measurement is used to quantify nasalance. Pharyngeal wall injection, if indicated, is performed under endoscopic or direct visualization in a clinical setting. |
| Evidence status | Currently under investigation; results for diagnostic feasibility, measurement accuracy, and intervention effects are not yet established in this trial. | Instrumental and endoscopic diagnostic approaches are recommended and widely used in practice, with validation studies supporting their accuracy for characterizing VPD. Nasometry is validated for measuring nasalance, though may require patient- and language-specific interpretation. |
| Important limitations | Being a small pilot study, it is limited by sample size, feasibility/resource constraints, and absence of a randomized comparator. Its findings may not generalize across all clinical settings until validated. | While standard diagnostic approaches are established, their availability and expertise may vary. Nasometry and perceptual assessments can be influenced by language, clinician training, and underlying comorbidities in post–head and neck cancer populations. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline assessments conducted over 1 to 2 visits
Participants undergo a multidisciplinary evaluation including physical examination, flexible nasolaryngoscopy, acoustic speech analysis, nasometry, clinical swallowing assessment, and fiberoptic endoscopic evaluation of swallowing (FEES) to characterize velopharyngeal dysfunction.
1 to 2 visits (in-person)
Duration - One-time procedure with post-procedure assessments
Participants with confirmed velopharyngeal dysfunction who meet clinical criteria may receive a single pharyngeal wall augmentation injection to improve velopharyngeal closure during speech and swallowing.
1 visit for injection and follow-up visits at 6 weeks and 6 months post injection
Duration - 6 months post injection
Participants who receive pharyngeal wall augmentation have follow-up assessments to evaluate speech intelligibility, nasalance, swallowing function, and patient-reported outcomes.
Follow-up visits at 6 weeks and 6 months post injection
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/18570960/Vanessa Torrecillas
Lead Sponsor