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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
