An observational study in Dysphagia, sponsored by IRCCS San Camillo, Venezia, Italy. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by IRCCS San Camillo, Venezia, Italy · Observational
This study aims to translate and validate Italian versions of several clinical assessment tools for patients with neurogenic dysphagia. The instruments include:
The New Zealand Secretion Severity Scale, which evaluates secretion management; The Reflex Cough Test from the I\&I cranial nerves assessment; The VASES scale used during fiberoptic endoscopic evaluation of swallowing; The Drooling Severity Scale, which measures saliva control.
The study will include approximately 100 patients with neurogenic dysphagia. The goal is to provide reliable, standardized tools in Italian to support clinicians in assessing swallowing and oral-motor function in patients with neurological disorders.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 100 is above the median of 84 across 249 observational studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →IRCCS San Camillo, Venezia, Italy is the lead sponsor of 48 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
people with neurogenic dysphagia
IInclusion Criteria:
Adult patients (≥18 years) diagnosed with neurogenic dysphagia due to any neurological condition (e.g., stroke, Parkinson's disease, multiple sclerosis, traumatic brain injury) Able to understand and comply with study procedures Provide written (or legal representative consent if necessary) Stable medical and neurological condition at the time of assessment
Exclusion Criteria:
Active respiratory infection or acute illness affecting swallowing at the time of assessment History of head and neck surgery or anatomical abnormalities preventing standardized assessment of swallowing or reflex cough Severe uncontrolled comorbidities (cardiac, pulmonary, or systemic) that make study participation unsafe
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.
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.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
no intervention but validation of assessments
Internal consistency of secretion and drooling scales
Description: Internal consistency of the New Zealand Secretions Severity Scale (NZSS) and Drooling Severity Scale (DSS). Scale titles: New Zealand Secretions Severity Scale (NZSS) Drooling Severity Scale (DSS) Range: NZSS: 0-7 (higher score = greater secretion severity) DSS: 1-5 (higher score = greater drooling severity) Metric: Cronbach's alpha (0-1; higher = better consistency)
Time frame: Baseline
Inter-rater reliability of secretion, drooling, and swallowing assessment scales
Inter-rater reliability of secretion, drooling, and swallowing assessment scales Scale titles: New Zealand Secretions Severity Scale (NZSS) Drooling Severity Scale (DSS) Visual Analysis of Swallowing efficiency and safety (VASES) Range: NZSS: 0-7 (higher = worse secretion severity) DSS: 1-5 (higher = worse drooling severity) VASES: - pharyngeal residue: 0-4 (higher = worse residue severity); PAS: 1-8 (higher = worse airway invasion severity) Metric: Intraclass Correlation Coefficient (ICC, 0-1; higher = better reliability)
Time frame: baseline
Test-retest reliability of clinical swallowing and secretion measures
Test-retest reliability of clinical swallowing and secretion measures Scale titles: New Zealand Secretions Severity Scale (NZSS) Drooling Severity Scale (DSS) Reflex Cough Test Range: NZSS: 0-7 DSS: 1-5 Reflex Cough Test: 0-4 (based on increasing citric acid concentrations 0.1-0.4; higher = worse cough reflex sensitivity impairment) Metric: Intraclass Correlation Coefficient (ICC, 0-1; higher = better reliability)
Time frame: Time Frame: Baseline and 7 days
Construct validity of secretion and drooling scales during FEES
Construct validity of secretion and drooling scales during FEES Scale titles: New Zealand Secretions Severity Scale (NZSS) Drooling Severity Scale (DSS) VASES (Visual Analysis of Swallowing Efficiency and Safety) Range: NZSS: 0-7 DSS: 1-5 VASES: pharyngeal residue: 0-4 (higher = worse residue severity); PAS: 1-8 (higher = worse airway invasion severity) Metric: Correlation coefficients (-1 to +1; absolute value closer to 1 = stronger association)
Time frame: Time Frame: Baseline
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Dec 2028, 45 months after the start.
Of 117 non-industry observational studies under Deglutition Disorders, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 52. This study's planned 45 months is above that.
Counting every sponsor, half of 120 studies reached it within 25 months; a quarter within 11 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
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IRCCS San Camillo, Venezia, Italy