Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 4:35 AM
Study NCT ID:
NCT05733494
Status:
RECRUITING
Last Update Posted:
2025-02-04
First Post:
2023-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cross Cultural Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2023-02-08', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Assessment of Dysphagia in Neurodegeneration (CADN)', 'timeFrame': 'at the enrolment', 'description': '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).'}, {'measure': 'Clinical Assessment of Dysphagia in Neurodegeneration (CADN)', 'timeFrame': 'at 24 hours from enrolment', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Fiberoptic Endoscopic Evaluation of Swallowing (FEES)', 'timeFrame': 'At the enrolment', 'description': 'Instrumental examination, gold standard for the assessment of dysphagia.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Swallowing Disorder', 'Dysphagia', 'Neuro-Degenerative Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nCurrently, there is no validated tool in Italian specific for the clinical assessment of dysphagia in neurodegenerative disease with strong psychometric characteristics.\n\nThe present study aims to translate and validate the Italian version of CADN in neurodegenerative population. Psychometric properties will be measured.', 'detailedDescription': '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).\n\nDysphagia 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.\n\nEarly 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.\n\nThe English version of the "Clinical Assessment of Dysphagia in Neurodegeneration" (CADN), represents a rapid and valid clinical assessment tool for dysphagia in neurodegenerative population.\n\nCurrently, there is no validated tool in Italian specific for the clinical assessment of dysphagia in neurodegenerative disease with strong psychometric characteristics.\n\nThe present study aims to translate and validate the Italian version of CADN in neurodegenerative population.\n\nThe study will be carried out in two phases:\n\n1. Forward and back translation\n2. Validation process'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with neurodegenerative disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of neurodegenerative disease according to the respective consensus criteria\n* \\>18 years old\n* able to provide informed consent\n* able to follow simple instructions\n* capable of sitting upright for anamnesis and examination for at least 20 min (in chair or wheelchair)\n\nExclusion Criteria:\n\n* history of stroke\n* surgery to the head or neck\n* radiotherapy in the last 12 months\n* dysphagia resulting from other known causes'}, 'identificationModule': {'nctId': 'NCT05733494', 'briefTitle': 'Cross Cultural Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration', 'organization': {'class': 'OTHER', 'fullName': 'Istituti Clinici Scientifici Maugeri SpA'}, 'officialTitle': 'Cross-Cultural Adaptation and Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration (CADN)', 'orgStudyIdInfo': {'id': 'CE2622'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with neurodegenerative disease', 'description': 'Patients with neurodegenerative disease', 'interventionNames': ['Other: Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)']}], 'interventions': [{'name': 'Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)', 'type': 'OTHER', 'description': 'the CADN will be administrated to each patient at the enrolment', 'armGroupLabels': ['Patients with neurodegenerative disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20138', 'city': 'Milan', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Micol Castellari', 'role': 'CONTACT', 'email': 'micol.castellari@icsmaugeri.it', 'phone': '+ 39 3392234850'}], 'facility': 'Istituti Clinici Scientifici Maugeri', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Micol Castellari, Speech-Language Pathologist', 'role': 'CONTACT', 'email': 'micol.castellari@icsmaugeri.it', 'phone': '3392234850', 'phoneExt': '+ 39'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituti Clinici Scientifici Maugeri SpA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Speech-Language Pathologist', 'investigatorFullName': 'Micol Castellari', 'investigatorAffiliation': 'Istituti Clinici Scientifici Maugeri SpA'}}}}