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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034924
Receipt No. R000039827
Scientific Title Evaluation of tinnitus treating sound in Tinnitus Retraining Therapy
Date of disclosure of the study information 2018/11/21
Last modified on 2018/11/18

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Basic information
Public title Evaluation of tinnitus treating sound in Tinnitus Retraining Therapy
Acronym Evaluation of tinnitus treating sound in TRT
Scientific Title Evaluation of tinnitus treating sound in Tinnitus Retraining Therapy
Scientific Title:Acronym Evaluation of tinnitus treating sound in TRT
Region
Japan

Condition
Condition tinnitus
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the effect of new tinnitus treating sound in tinnitus patients in tinnitus retraining therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tinnitus Loudness
Key secondary outcomes Tinnitus Handicap Inventory

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Tinnitus Retraining Therapy: TRT
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 Patients who visit with tinnitus of one ear or both ears as the main symptoms, have tinnitus frequencies of 4 kHz or more mainly by tinnitus pitch match examination, and are judged suitable for treatment by TRT therapy.
Key exclusion criteria none
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takenori Miyashita
Organization Kagawa University
Division name Department of Otolaryngology, Faculty of Medicine
Zip code
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL 087-891-2214
Email chiho@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takenori Miyashita
Organization Kagawa University
Division name Department of Otolaryngology, Faculty of Medicine
Zip code
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL 087-891-2214
Homepage URL
Email chiho@med.kagawa-u.ac.jp

Sponsor
Institute Department of Otolaryngology, Faculty of Medicine, Kagawa University
Institute
Department

Funding Source
Organization Kagawa University
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
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 香川大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 21 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
2018 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 21 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 18 Day
Last modified on
2018 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039827

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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