Swallowing DisorderNCT05733494
Cross Cultural Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration
An observational study of Swallowing Disorder and Dysphagia, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
The English version of the "Clinical Assessment of Dysphagia in Neurodegeneration" (CADN), represents a rapid and valid clinical assessment tool for dysphagia in neurodegenerative population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swallowing Disorder, Dysphagia, Neuro-Degenerative Disease
- What is being tested?
- Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
- How many people
- 101 participants
- Where
- 1 siteItaly
- Study dates
- 5 Apr 2022to 16 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with neurodegenerative disease
Who may be able to join
- diagnosis of neurodegenerative disease according to the respective consensus criteria
- >18 years old
- able to provide informed consent
- able to follow simple instructions
- capable of sitting upright for anamnesis and examination for at least 20 min (in chair or wheelchair)
Who cannot join
- history of stroke
- surgery to the head or neck
- radiotherapy in the last 12 months
- dysphagia resulting from other known causes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-Cultural Adaptation and Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
The English version of the "Clinical Assessment of Dysphagia in Neurodegeneration" (CADN), represents a rapid and valid clinical assessment tool for dysphagia in neurodegenerative population.
Currently, there is no validated tool in Italian specific for the clinical assessment of dysphagia in neurodegenerative disease with strong psychometric characteristics.
The present study aims to translate and validate the Italian version of CADN in neurodegenerative population. Psychometric properties will be measured.
Read the detailed description
Most of patients with a neurodegenerative disease will develop swallowing impairments (dysphagia) during their disease progression (up to 80%- 100% in Parkinson disease and Amyotrophic Lateral Sclerosis).
Dysphagia is associated with serious clinical complications, particularly regarding loss of life quality, insufficient medication intake, malnutrition, dehydration, and aspiration with subsequent pneumonia, which is the leading cause of death in this population.
Early detection and measurement of dysphagia trough validated and standardized procedures plays a fundamental role in the clinical practice. Clinical assessment by a speech language pathologist (SLP) can provide early identification of dysphagia and its severity and direct clinical decision making.
The English version of the "Clinical Assessment of Dysphagia in Neurodegeneration" (CADN), represents a rapid and valid clinical assessment tool for dysphagia in neurodegenerative population.
Currently, there is no validated tool in Italian specific for the clinical assessment of dysphagia in neurodegenerative disease with strong psychometric characteristics.
The present study aims to translate and validate the Italian version of CADN in neurodegenerative population.
The study will be carried out in two phases:
- Forward and back translation
- Validation process
- Conditions
- Swallowing Disorder, Dysphagia, Neuro-Degenerative Disease
- Being tested
- Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)Other
the CADN will be administrated to each patient at the enrolment
| Study group | Role | What they receive |
|---|---|---|
| Patients with neurodegenerative disease | Patients with neurodegenerative disease Receives: Other: Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
Clinical assessment tool administrated by a Speech Language Pathologist. The CADN is composed by a clinical case history and a consumption part for a total of 11 item. Severity scores for each item range from 0 (no impairment) to 4 (severe impairment).
Measured: at the enrolment
Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
Clinical assessment tool administrated by a Speech Language Pathologist. The CADN is composed by a clinical case history and a consumption part for a total of 11 item. Severity scores for each item range from 0 (no impairment) to 4 (severe impairment).
Measured: at 24 hours from enrolment
Secondary outcomes (1)
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Instrumental examination, gold standard for the assessment of dysphagia.
Measured: At the enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start5 Apr 2022
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Micol Castellari, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733494
- Sponsor's protocol ID
- CE2622
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2023
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Adaptation and Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
- ClinicalTrials.gov ID
- NCT05733494
- Acronym / sponsor ID
- CE2622
- Conditions
- Swallowing Disorder, Dysphagia, Neuro-Degenerative Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 17 Feb 2023 (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.
The English version of the "Clinical Assessment of Dysphagia in Neurodegeneration" (CADN), represents a rapid and valid clinical assessment tool for dysphagia in neurodegenerative population.
Currently, there is no validated tool in Italian specific for the clinical assessment of dysphagia in neurodegenerative disease with strong psychometric characteristics.
The present study aims to translate and validate the Italian version of CADN in neurodegenerative population. Psychometric properties will be measured.
Detailed description
Most of patients with a neurodegenerative disease will develop swallowing impairments (dysphagia) during their disease progression (up to 80%- 100% in Parkinson disease and Amyotrophic Lateral Sclerosis).
Dysphagia is associated with serious clinical complications, particularly regarding loss of life quality, insufficient medication intake, malnutrition, dehydration, and aspiration with subsequent pneumonia, which is the leading cause of death in this population.
Early detection and measurement of dysphagia trough validated and standardized procedures plays a fundamental role in the clinical practice. Clinical assessment by a speech language pathologist (SLP) can provide early identification of dysphagia and its severity and direct clinical decision making.
The English version of the "Clinical Assessment of Dysphagia in Neurodegeneration" (CADN), represents a rapid and valid clinical assessment tool for dysphagia in neurodegenerative population.
Currently, there is no validated tool in Italian specific for the clinical assessment of dysphagia in neurodegenerative disease with strong psychometric characteristics.
The present study aims to translate and validate the Italian version of CADN in neurodegenerative population.
The study will be carried out in two phases:
- Forward and back translation
- Validation process
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with neurodegenerative disease | – | Other: Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)Patients with neurodegenerative disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with neurodegenerative disease
Key inclusion criteria (5 listed)
- diagnosis of neurodegenerative disease according to the respective consensus criteria
- >18 years old
- able to provide informed consent
- able to follow simple instructions
- capable of sitting upright for anamnesis and examination for at least 20 min (in chair or wheelchair)
Key exclusion criteria (4 listed)
- history of stroke
- surgery to the head or neck
- radiotherapy in the last 12 months
- dysphagia resulting from other known causes
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 |
|---|---|---|
| Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)the CADN will be administrated to each patient at the enrolment | Other | Patients with neurodegenerative disease |
Primary outcome
Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
Time frame: at the enrolment
Clinical assessment tool administrated by a Speech Language Pathologist. The CADN is composed by a clinical case history and a consumption part for a total of 11 item. Severity scores for each item range from 0 (no impairment) to 4 (severe impairment).
Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
Time frame: at 24 hours from enrolment
Clinical assessment tool administrated by a Speech Language Pathologist. The CADN is composed by a clinical case history and a consumption part for a total of 11 item. Severity scores for each item range from 0 (no impairment) to 4 (severe impairment).
1 secondary outcome
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Time frame: At the enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Swallowing Disorder and Dysphagia, run by Istituti Clinici Scientifici Maugeri SpA 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 2 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Assessment of Dysphagia in Neurodegeneration (CADN) (time frame: at the enrolment). The study lists 2 primary outcomes in all. 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 2 Mar 2026.