UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028503 |
|---|---|
| Receipt number | R000032619 |
| Scientific Title | validation and reliability of tinnitus handicap inventory revision |
| Date of disclosure of the study information | 2017/08/02 |
| Last modified on | 2017/08/02 18:14:07 |
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Basic information
Public title
validation and reliability of tinnitus handicap inventory revision
Acronym
validation and reliability of tinnitus handicap inventory revision
Scientific Title
validation and reliability of tinnitus handicap inventory revision
Scientific Title:Acronym
validation and reliability of tinnitus handicap inventory revision
Region
| Japan |
Condition
Condition
tinnitus
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
validation of THI revision
Basic objectives2
Others
Basic objectives -Others
reliability of THI revision
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
validation and reliability of THI revision
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
questionnaire
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
people who like to join the research
Key exclusion criteria
people who do not like to join the research
Target sample size
138
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sho Kanzaki |
Organization
Keio University
Division name
School of Medicine Dept Otolaryngology
Zip code
Address
35 Shinanomachi Shinjuku Tokyo
TEL
0353633827
skan@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho Kanzaki |
Organization
Keio University
Division name
School of Medicine Dept Otolaryngology
Zip code
Address
35 Shinanomachi Shinjuku Tokyo
TEL
0353633827
Homepage URL
skan@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Address
Tel
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
岩手医科大学、東北大学、筑波大学、名古屋市立大学、神戸医療センター、慶應義塾大学
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | 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
| 2017 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2017 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032619
