DysphagiaVal_DysphagiaNCT07549724
Clinical and Instrumental Assessment Tools for Neurogenic Dysphagia: Translation and Validation
An observational study of Dysphagia, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- dysphagia assessment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 9 Mar 2025to 30 Dec 2028
- How long will I take part?
- 1 Week
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people with neurogenic dysphagia
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Camillo
Venezia, Italy, 30126
Sara Nordio, PhD, 3494990310, sara.nordio@hsancamillo.it
About this study
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.
- Conditions
- Dysphagia
- Being tested
- dysphagia assessment
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dysphagia assessmentDiagnostic test
no intervention but validation of assessments
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Secondary outcomes (1)
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)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start9 Mar 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Nordio, IRCCS San Camillo, Venezia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549724
- Sponsor's protocol ID
- 6111/S.Camillo/24
- Other IDs
- Italian Ministry of Health
- Acronym
- Val_Dysphagia
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Instrumental Assessment Tools for Neurogenic Dysphagia: Translation and Validation
- ClinicalTrials.gov ID
- NCT07549724
- Acronym / sponsor ID
- Val_Dysphagia / 6111/S.Camillo/24
- Conditions
- Dysphagia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 9 Mar 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 24 Apr 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people with neurogenic dysphagia
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| dysphagia assessmentno intervention but validation of assessments | Diagnostic test | – |
Primary outcome
Internal consistency of secretion and drooling scales
Time frame: Baseline
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)
1 secondary outcome
Inter-rater reliability of secretion, drooling, and swallowing assessment scales
Time frame: baseline
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 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
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 0 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 24 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 Italy. 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 Sara Nordio (3494990310, sara.nordio@hsancamillo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal consistency of secretion and drooling scales (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2026.