UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034924
Receipt number 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 2020/03/16 22:47:00

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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 or person

Institute

Department of Otolaryngology, Faculty of Medicine, Kagawa University

Institute

Department

Personal name



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

Enrolling by invitation

Date of protocol fixation

2018 Year 10 Month 11 Day

Date of IRB

2018 Year 10 Month 04 Day

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

2020 Year 03 Month 16 Day



Link to view the page

Value
https://center6.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