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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013861
Receipt No. R000016152
Scientific Title Evaluation of relationships between swallowing function and prognostic factors in patients with chronic obstructive pulmonary disease
Date of disclosure of the study information 2014/07/01
Last modified on 2019/10/19

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Basic information
Public title Evaluation of relationships between swallowing function and prognostic factors in patients with chronic obstructive pulmonary disease
Acronym Evaluation of relationships between swallowing function and prognostic factors in patients with chronic obstructive pulmonary disease
Scientific Title Evaluation of relationships between swallowing function and prognostic factors in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym Evaluation of relationships between swallowing function and prognostic factors in patients with chronic obstructive pulmonary disease
Region
Japan

Condition
Condition Chronic Obstructive Pulmonary Disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate swallowing function in patients with chronic obstructive pulmonary disease (COPD) and prospectively study the relationships between swallowing function and prognostic factors.
Basic objectives2 Others
Basic objectives -Others We evaluate swallowing function during eating property-adjusted test foods and during sleep in patients with COPD, and prospectively study the relationships between swallowing function and prognostic factors such as exacerbation, decline of lung function, and progression of emphysema based on CT images.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Exacerbation, decline of lung function, and progression of emphysema based on CT images within one year categorized by swallowing function at the start point
Key secondary outcomes Relationship between COPD staging and swallowing function

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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients whose FEV1.0% is less than 70%, or clinically diagnosed as emphysema or chronic bronchitis
2. Smoking: 20 pack-year or greater
3. Patients who use diaries to record daily symptoms
Key exclusion criteria 1. Patients whose primary symptom is associated with bronchial asthma
2. Patients with malignant neoplasms or having histories of malignant diseases within 5 years
3. Patients with cerebrovascular diseases or having histories of cerebrovascular diseases
4. Patients having histories of aspiration pneumonia within 2 years
5. Patients taking dopaminergic drugs or ACE inhibitors
6. Patients treated with cardiac pacemakers
7. Patients with apparent dementia (MMSE < 20)
8. Patients who have difficulties in conducting spirometry
9. Patients who declined to participate in the study
10. Patients who were judged as inappropriate to be enrolled by the doctor in charge
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Muro
Organization Kyoto university
Division name Respiratory Medicine
Zip code
Address 54Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL +81-75-751-3830
Email smuro@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeo Muro
Organization Kyoto university
Division name Respiratory Medicine
Zip code
Address 54Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL +81-75-751-3830
Homepage URL
Email smuro@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital Clinical Research Center for Medical Equipment Development
Institute
Department

Funding Source
Organization J Craft Co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications https://bmjopenrespres.bmj.com/content/4/1/e000202
Number of participants that the trial has enrolled
Results
Breathing-swallowing discoordination is strongly associated with frequent exacerbations of COPD. Strategies that identify and improve breathing-swallowing coordination may be a new therapeutic treatment for patients with COPD.
Results date posted
2019 Year 10 Month 19 Day
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 No longer recruiting
Date of protocol fixation
2014 Year 04 Month 14 Day
Date of IRB
2014 Year 07 Month 01 Day
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Swallowing states during adjusted test foods eating and sleep in COPD patients are monitored using a non-invasive swallowing activity monitoring and analysis system that recognizes swallowing and assesses swallowing function by analyzing relationships among swallowing sound, laryngeal motion, and respiration.

Management information
Registered date
2014 Year 05 Month 01 Day
Last modified on
2019 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016152

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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