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NCT Number: NCT07549724

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

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Camillo

Venezia, Italy, 30126

Location status: Recruiting

Location contact

Sara Nordio, PhD

CONTACT

[email protected]

3494990310

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dysphagia assessment

Diagnostic Test

no intervention but validation of assessments

Primary outcomes

  1. 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)

Secondary outcomes

  1. Inter-rater reliability of secretion, drooling, and swallowing assessment scales

    Time frame: baseline

    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)

Other outcomes

  1. Test-retest reliability of clinical swallowing and secretion measures

    Time frame: Time Frame: Baseline and 7 days

    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)

  2. Construct validity of secretion and drooling scales during FEES

    Time frame: Time Frame: Baseline

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Nordio

CONTACT

[email protected]

3494990310

Sponsors and collaborators

Lead sponsor

IRCCS San Camillo, Venezia, Italy

Other

Registry information

Acronym: Val_Dysphagia

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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