Clinical trial Recruiting at 1 site Observational Ages 18 to 85

Italian versions of swallowing and drooling assessment tools for adults with neurogenic dysphagia

Official title: Clinical and Instrumental Assessment Tools for Neurogenic Dysphagia: Translation and Validation

Run by IRCCS San Camillo, Venezia, Italy · NCT07549724 · Data updated 2026-11-12

This project will test Italian versions of several swallowing and drooling assessment tools in adults with neurogenic dysphagia to see if they are reliable and usable.

More Dysphagia trials

Quick facts

Study typeObservational
Ages18 Years to 85 Years
SexAll
Enrollment100 (estimated)
SponsorIRCCS San Camillo, Venezia, Italy
Academic / other
Locations1 site (Venezia, Italy)
StatusRecruiting
StartedMarch 9, 2025
Main results expectedDecember 30, 2028
Study endsDecember 30, 2028
Registry record updatedApril 24, 2026
Trial IDNCT07549724 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18 years or older) with neurogenic dysphagia from any neurological condition who are medically stable and able to provide informed consent are ideal candidates.

Probably not a fit

People with an active respiratory infection, recent head or neck surgery or anatomical abnormalities preventing standardized assessment, or severe uncontrolled comorbidities are unlikely to receive benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will translate and culturally adapt four established instruments—the New Zealand Secretion Severity Scale, the Reflex Cough Test, the VASES used during fiberoptic endoscopic evaluation of swallowing (FEES), and the Drooling Severity Scale—into Italian. About 100 adult patients with neurogenic dysphagia from various neurological conditions will be enrolled at a single center in Venice. The protocol is observational and will examine measurement properties such as inter-rater and intra-rater reliability, and validity against clinical and instrumental swallowing findings. The goal is to produce standardized, linguistically and psychometrically validated Italian tools for use in routine clinical and research settings.

Why it matters

Potential benefit: If successful, clinicians in Italy would have reliable, standardized Italian tools to better identify and monitor swallowing and drooling problems and guide treatment decisions.

How similar studies have gone: The individual instruments are established and have been validated in other languages, but validated Italian versions are new and have not yet been tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 informed consent (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

Where it's running

  • IRCCS San Camillo
    Venezia, Italy, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.