Tokyo, Sept. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059191) titled 'A Multicenter Prospective Observational Study of Dysphagia and Dysphonia in Interstitial Lung Disease: R6-EBM(Kokyu)-01' on Sept. 29.

Study Type: Observational

Primary Sponsor: Institute - NHO Kinki Chuo Chest Medical Center

Condition: Condition - Interstitial lung disease: ILD, including Idiopathic pleuroparenchymal fibroelastosis: IPPFE and Idiopathic pulmonary fibrosis: IPF Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the prevalence, clinical features, and prognostic impact of dysphagia and dysphonia in ILD through a prospective observational study Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Diagnosis of IPPFE or IPF: Eligible participants include those diagnosed with IPPFE or IPF, as determined by the attending physician at each participating institution. In cases of combined disease, classification should be based on the predominant radiological and/or clinical features of either IPPFE or IPF. Key exclusion criteria - Patients meeting any of the following conditions are excluded from the study: A confirmed diagnosis of collagen vascular disease, hypersensitivity pneumonitis, pneumoconiosis, or drug induced interstitial lung disease. Active or Preceding Pulmonary Infections Post Transplant Status Poor General Condition: Patients with an ECOG Performance Status of 4. Limited Life Expectancy: Patients with an estimated life expectancy of less than 3 months due to non ILD related comorbidities or complications. Advanced Malignancy: Patients with incurable advanced stage malignancy. Impaired Consciousness: Patients with a decreased level of consciousness worse than Japan Coma Scale I2. Oropharyngeal Structural Disease: Patients with known head and neck diseases that may independently cause swallowing dysfunction. Neurological Sequelae of Stroke: Patients with post ischemic cerebral infarction presenting with obvious motor paralysis or swallowing dysfunction attributed to the stroke. Neurodegenerative Disorders: Patients with dementia or Parkinsons disease when associated with swallowing dysfunction. Neuromuscular Disorders: Patients diagnosed with neuromuscular diseases such as amyotrophic lateral sclerosis, myasthenia gravis, or polymyositis. Use of Certain Medications: Patients who are regularly taking antipsychotic medications or anticonvulsants. Investigators Discretion: Patients deemed unsuitable for participation by the Principal Investigator or site Research Supervisor for any reason. Target Size - 300

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 04 Month 10 Day Date of IRB - 2025 Year 02 Month 21 Day Anticipated trial start date - 2025 Year 05 Month 23 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066098

Disclaimer: Curated by HT Syndication.