UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037342 |
|---|---|
| Receipt number | R000042575 |
| Scientific Title | Post-earthquake dizziness in Kummaoto, Japan |
| Date of disclosure of the study information | 2019/07/12 |
| Last modified on | 2019/07/12 11:27:15 |
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Basic information
Public title
Post-earthquake dizziness in Kummaoto, Japan
Acronym
Post-earthquake dizziness in Kumamoto
Scientific Title
Post-earthquake dizziness in Kummaoto, Japan
Scientific Title:Acronym
PED in Kumamoto
Region
| Japan |
Condition
Condition
Post-earthquake dizziness
Classification by specialty
| Oto-rhino-laryngology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Major earthquakes are associated with increased dizziness; however, the types and causes of dizziness are unknown. To examine how major earthquakes and repetitive aftershocks influence the human equilibrium system.
Basic objectives2
Others
Basic objectives -Others
To examine the mechanism of major earthquakes and repetitive aftershocks-induced dizziness.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome was post-earthquake dizziness (PED).
Key secondary outcomes
Secondary outcomes were PED is affected by vestibular and autonomic dysfunction.
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy participants who were exposed to the Kumamoto earthquakes and aftershocks and participants with vestibular diseases examined after the Kumamoto earthquakes and aftershocks.
Key exclusion criteria
Participants who were not exposed to the Kumamoto earthquakes and aftershocks.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Ryosei |
| Middle name | |
| Last name | Minoda |
Organization
Kumamoto University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
860-8556
Address
1-1-1 Honjo, Kumamoto, Japan
TEL
0963735255
miw.com1101@gmail.com
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Miwa |
Organization
Kumamoto University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
860-8556
Address
1-1-1 Honjo, Kumamoto, Japan
TEL
0963735255
Homepage URL
miw.com1101@gmail.com
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University
Address
1-1-1, Honjo, Kumamoto, Japan
Tel
0963735255
miw.com1101@gmail.com
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
熊本大学病院(熊本県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 12 | 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
4231
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Questionnaire survey and equilibrium test were performed and collected.
Management information
Registered date
| 2019 | Year | 07 | Month | 12 | Day |
Last modified on
| 2019 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042575
| 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 |
