UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055408 |
|---|---|
| Receipt number | R000063323 |
| Scientific Title | Development of rehabilitation methods for unilateral hearing loss |
| Date of disclosure of the study information | 2025/02/07 |
| Last modified on | 2025/03/05 17:11:58 |
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Basic information
Public title
Development of rehabilitation methods for unilateral hearing loss
Acronym
rehabilitation for unilateral hearing loss
Scientific Title
Development of rehabilitation methods for unilateral hearing loss
Scientific Title:Acronym
rehabilitation for unilateral hearing loss
Region
| Japan |
Condition
Condition
unilateral hearing loss
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether various existing auditory compensation devices and new rehabilitation can improve directional localization and hearing in noise for unilateral hearing loss.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improved performance on the directionality test and speech in noise test
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Hearing training at home
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases with unilateral hearing loss after language acquisition and wearing hearing compensation devices (hearing aids or cochlear implants)
Cases between 18 and 75 years old
Cases with unilateral moderate or greater (average 40 dB or greater) sensorineural hearing loss after language acquisition
No change in hearing ability for more than 3 months
Japanese as a first language
Key exclusion criteria
The patient has difficulty wearing hearing compensation devices
Hearing loss before language acquisition
First language is a foreign language
Other conditions judged by the physician to be inappropriate for the subject to undergo this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | TADAO |
| Middle name | |
| Last name | YOSHIDA |
Organization
Nagoya University School of Medicine
Division name
Otolaryngology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442323
tadaoy@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | TADAO |
| Middle name | |
| Last name | YOSHIDA |
Organization
Nagoya university
Division name
Medicine, Otorhinolaryngology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442323
Homepage URL
tadaoy@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Nagoya university, Department of Ethics Review Committee
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
0527412111
ethics@med.nagoya-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 07 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063323
