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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028503
Receipt No. 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

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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
Email 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
Email skan@keio.jp

Sponsor
Institute Keio University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032619

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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