UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063146 |
|---|---|
| Receipt number | R000071957 |
| Scientific Title | Effect of Cough Sound on Multidimensional Nature of Breathlessness. |
| Date of disclosure of the study information | 2026/10/02 |
| Last modified on | 2026/10/02 10:12:36 |
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Basic information
Public title
Effect of cough sound on breathlessness.
Acronym
Cough Sound on Breathlessnss
Scientific Title
Effect of Cough Sound on Multidimensional Nature of Breathlessness.
Scientific Title:Acronym
CSMB study
Region
| Japan |
Condition
Condition
Effect of Cough sounds on Multidimensional Dyspnea.
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of cough sounds on multidimensional dyspnea.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
The Japanese version of Multidimensional Dyspnea Profile.
Key secondary outcomes
The frequency of breathing, tidal volume and inspiratory neural drive.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Auditory stimulation with cough sounds and active noise cancelling.
Interventions/Control_2
Auditory stimulation with active noise cancelling.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy young men with normal pulmonary function
Key exclusion criteria
[Exclusion criteria] (1) History of chronic respiratory diseases (asthma, COPD, chronic cough) or acute upper respiratory tract infection within the preceding 4 weeks; (2) Auditory disorders or hearing impairment; (3) Current or past history of smoking; and (4) Use of respiratory, antitussive, or neuromodulatory medications.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Kanezaki |
Organization
Tokyo International University
Division name
School of Health Sciences
Zip code
350-1197
Address
1-13-1, Matobakita, Kawagoe, Saitama 350-1197, JAPAN
TEL
050-3536-0169
mkaneza@tiu.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Kanezaki |
Organization
Tokyo International University
Division name
School of Health Sciences
Zip code
3501197
Address
1-13-1, Matobakita, Kawagoe, Saitama 350-1197, JAPAN
TEL
05035360169
Homepage URL
mkaneza@tiu.ac.jp
Sponsor or person
Institute
Tokyo International Univesity
Institute
Department
Personal name
Masashi Kanezaki
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo International University
Address
1-13-1, Matobakita, Kawagoe, Saitama 350-1197, JAPAN
Tel
049-232-1111
kenkyujosei@tiu.ac.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
| 2026 | Year | 10 | Month | 02 | 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
| 2026 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 02 | Day |
Last modified on
| 2026 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071957
