UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059326 |
|---|---|
| Receipt number | R000067863 |
| Scientific Title | An Exploratory Study on Auditory Training Methods for Hearing Aid Users |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/08 01:34:34 |
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Basic information
Public title
An Exploratory Study on Auditory Training Methods for Hearing Aid Users
Acronym
Exploratory Study on a Novel Auditory Training Method
Scientific Title
An Exploratory Study on Auditory Training Methods for Hearing Aid Users
Scientific Title:Acronym
Exploratory Study on a Novel Auditory Training Method
Region
| Japan |
Condition
Condition
Sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a New Auditory Training Method for Individuals with Mild to Moderate Hearing Loss
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in Speech Discrimination Under Noise
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
With Auditory Training
Interventions/Control_2
Without Auditory Training
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with mild to moderate hearing loss with an average hearing level below 70 dB HL
2. Currently wearing hearing aids in both ears or in the better-hearing ear
3. Continuous daily wear of hearing aids for six months or longer
Key exclusion criteria
1. Individuals with a history of peripheral or central nervous system disorders
2. Individuals scoring below the standard threshold on the cognitive function test (MMSE)
3. Individuals deemed unsuitable as subjects by the principal investigator or co-investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Katori |
Organization
Tohoku University
Division name
Otolaryngology Head & Neck Surgery
Zip code
9808574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7304
yohei.honkura.d5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Honkura |
Organization
Tohoku University
Division name
Otolaryngology Head & Neck Surgery
Zip code
980574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7304
Homepage URL
yohei.honkura.d5@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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 | 10 | Month | 08 | 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
| 2025 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067863
