UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059191 |
|---|---|
| Receipt number | R000066098 |
| Scientific Title | A Multicenter Prospective Observational Study of Dysphagia and Dysphonia in Interstitial Lung Disease: R6-EBM(Kokyu)-01 |
| Date of disclosure of the study information | 2025/09/29 |
| Last modified on | 2025/09/25 13:26:32 |
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Basic information
Public title
A Multicenter Prospective Observational Study of Dysphagia and Dysphonia in Interstitial Lung Disease: R6-EBM(Kokyu)-01
Acronym
A Multicenter Prospective Observational Study of Dysphagia and Dysphonia in Interstitial Lung Disease: R6-EBM(Kokyu)-01
Scientific Title
A Multicenter Prospective Observational Study of Dysphagia and Dysphonia in Interstitial Lung Disease: R6-EBM(Kokyu)-01
Scientific Title:Acronym
A Multicenter Prospective Observational Study of Dysphagia and Dysphonia in Interstitial Lung Disease: R6-EBM(Kokyu)-01
Region
| Japan |
Condition
Condition
Interstitial lung disease: ILD, including Idiopathic pleuroparenchymal fibroelastosis: IPPFE and Idiopathic pulmonary fibrosis: IPF
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
To determine the prevalence of dysphagia and dysphonia in ILD and evaluate their impact on the incidence of pneumonia and acute exacerbations.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the clinical status of dysphagia and dysphonia in ILD and to compare the prevalence of dysphagia and dysphonia between IPPFE and IPF.
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Takimoto |
Organization
NHO Kinki Chuo Chest Medical Center
Division name
Clinical Research Center
Zip code
5918555
Address
1180 Nagasone-cho, Kita-ku, Sakai, Osaka
TEL
0722523021
takimoto.takayuki.ra@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Takimoto |
Organization
NHO Kinki Chuo Chest Medical Center
Division name
R6-EBM(Kokyu)-01 Administrative Office, Clinical Research Center
Zip code
5918555
Address
1180 Nagasone-cho, Kita-ku, Sakai, Osaka
TEL
0722523021
Homepage URL
409-enge@mail.hosp.go.jp
Sponsor or person
Institute
NHO Kinki Chuo Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
NHO Kinki Chuo Chest Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo
Tel
0357125075
700-kenkyu@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Background:
Swallowing and phonatory disorders have not been systematically studied in patients with interstitial lung diseases (ILDs). These complications may be associated with impaired quality of life and poor prognosis, particularly in idiopathic pleuroparenchymal fibroelastosis (IPPFE) and idiopathic pulmonary fibrosis (IPF).
Purpose:
To prospectively investigate the prevalence, incidence, and prognostic impact of swallowing and phonatory disorders in patients with IPPFE and IPF.
Study Design: Prospective observational study
Registration period: 2 years
Observation period: 3 years
Study Population:
Patients diagnosed with idiopathic pleuroparenchymal fibroelastosis (IPPFE) or idiopathic pulmonary fibrosis (IPF).
Primary Endpoint:
Comparison of the prevalence of swallowing and phonatory disorders between patients with IPPFE and those with IPF.
Secondary Endpoints:
Incidence of new clinical events according to the presence or absence of swallowing disorders in IPPFE and IPF.
Identification of prognostic factors related to swallowing disorders in both disease groups.
Target Sample Size:150 patients with IPPFE, 150 patients with IPF
Management information
Registered date
| 2025 | Year | 09 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066098
