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A Multicenter Prospective Observational Study of Dysphagia and Dysphonia in Interstitial Lung Disease: R6-EBM(Kokyu)-01

A Multicenter Prospective Observational Study of Dysphagia and Dysphonia in Interstitial Lung Disease: R6-EBM(Kokyu)-01 - A Multicenter Prospective Observational Study of Dysphagia and Dysphonia in Interstitial Lung Disease: R6-EBM(Kokyu)-01

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000059191
Enrollment
300
Registered
2025-09-29
Start date
2025-05-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial lung disease: ILD, including Idiopathic pleuroparenchymal fibroelastosis: IPPFE and Idiopathic pulmonary fibrosis: IPF

Interventions

None listed

Sponsors

NHO Kinki Chuo Chest Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
To assess the clinical status of dysphagia and dysphonia in ILD and to compare the prevalence of dysphagia and dysphonia between IPPFE and IPF.

Secondary

MeasureTime frame
1) To compare the prevalence of dysphagia between patients with IPPFE and IPF, using detailed assessments of swallowing function. 2) To compare the incidence of pneumonia, acute exacerbation of ILD, and dysphagia-related events between IPPFE and IPF patients. 3) To evaluate the incidence of pneumonia and acute exacerbation of ILD in IPPFE and IPF patients stratified by the presence or absence of dysphagia. 4) To identify risk factors for dysphagia, pneumonia, acute exacerbation of ILD, and dysphagia-related events in patients with IPPFE.

Countries

Japan

Contacts

Public ContactTakayuki Takimoto

NHO Kinki Chuo Chest Medical Center R6-EBM(Kokyu)-01 Administrative Office, Clinical Research Center

409-enge@mail.hosp.go.jp0722523021

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026