UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053205 |
|---|---|
| Receipt number | R000060709 |
| Scientific Title | Examination of hearing loss frequency and factors of impairment in kendo - Change in university students |
| Date of disclosure of the study information | 2023/12/22 |
| Last modified on | 2023/12/22 22:07:47 |
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Basic information
Public title
Examination of hearing loss frequency and factors of impairment in kendo - Change in university students
Acronym
Hearing loss in kendo club members of university student
Scientific Title
Examination of hearing loss frequency and factors of impairment in kendo - Change in university students
Scientific Title:Acronym
Hearing loss of kendo club members of university student
Region
| Japan |
Condition
Condition
hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The relationship between kendo experience and hearing loss has been many reported. However, no studies have been reported hearing loss in kendo in comparison to normal controls. In particular, the effects of aging are unknown. In addition, kendo is played in a special environment with noise and impact of the head. In previous reports, hearing loss has occurred in young people such as high school and university students. It is necessary to compare the frequency of hearing loss in young people with normal controls and to consider countermeasures from an early stage.
Basic objectives2
Others
Basic objectives -Others
Examination of the hearing loss risk factor by the living environment and exercise environment of Kendo
Hearing ability evaluation in kendo club members before and after practice
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pure tone audiometry
DPOAE
Key secondary outcomes
Measurement of noise in the training hall
Hearing ability evaluation in kendo club members before and after practice
Living environment survey
Kendo history and environment
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Juntendo university faculty of health and sports science kendo club members
Juntendo university faculty of health and sports science other athletic club members
Key exclusion criteria
Case with a history of treatment of previous irreversible ear disease
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Ito |
Organization
Juntendo university Urayasu Hospital
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
279-0021
Address
Tomioka2-1-1, Urayasu-city, Chiba
TEL
047-353-3111
shin709@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Ito |
Organization
Juntendo university Urayasu Hospital
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
279-0021
Address
Tomioka2-1-1, Urayasu-city, Chiba
TEL
047-353-3111
Homepage URL
shin709@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university Urayasu Hospital
Institute
Department
Personal name
Funding Source
Organization
All Japan Kendo Federation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Faculty of Medicine Juntendo University
Address
Hongo3-1-3, Bunkyou-ku, Tokyo
Tel
03-3814-5672
jcrtc_operation@juntendo.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
| 2023 | Year | 12 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of hearing loss frequency kendo club members with other athletic club members
Risk factors for hearing loss in kendo by questionnaire
Management information
Registered date
| 2023 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060709
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
