UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063094 |
|---|---|
| Receipt number | R000072084 |
| Scientific Title | Exploratory study on factors predicting the effectiveness of cochlear implants and hearing aids |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/29 14:11:57 |
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Basic information
Public title
Exploratory study on factors predicting the effectiveness of cochlear implants and hearing aids
Acronym
Exploratory study on factors predicting the effectiveness of cochlear implants and hearing aids
Scientific Title
Exploratory study on factors predicting the effectiveness of cochlear implants and hearing aids
Scientific Title:Acronym
Exploratory study on factors predicting the effectiveness of cochlear implants and hearing aids
Region
| Japan |
Condition
Condition
Sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The relationship between treatment methods (hearing aids, cochlear implants) and prognosis in patients with moderate to severe hearing loss is examined.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Speech perception performance with hearing aids or cochlear implants
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 55 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases of sensorineural hearing loss meeting the following criteria and seeking new treatment with hearing aids or cochlear implants:
(1) Aged 55 to 84 years
(2) Bilateral sensorineural hearing loss confirmed by pure-tone audiometry
(3) Pure-tone hearing threshold of the better-hearing ear between 40 dB HL and 90 dB HL (inclusive of 40, exclusive of 90)
(4) Maximum speech intelligibility score of the better-hearing ear is 60% or less
(5) Consent to participate in this study has been obtained
Key exclusion criteria
(1) Patients who have already received appropriate treatment with hearing aids or cochlear implants, and for whom no additional treatment is required
(2) Patients with otologic conditions unsuitable for hearing aids or cochlear implants
(3) Patients already diagnosed with dementia
(4) Other cases deemed inappropriate for study participation by investigator(s)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Oishi |
Organization
Keio University
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
160-8582
Address
35, Shinanomachi, Sinjuku-ku, Tokyo, Japan
TEL
03-5363-3827
ent-group@keio.jp
Public contact
Name of contact person
| 1st name | Marie |
| Middle name | |
| Last name | Shimanuki |
Organization
Keio University
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
160-8582
Address
35, Shinanomachi, Sinjuku-ku, Tokyo, Japan
TEL
03-5363-3827
Homepage URL
ent-group@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Cochlear Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35, Shinanomachi, Sinjuku-ku, Tokyo, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20261032
Org. issuing International ID_1
Keio University School of Medicine Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 30 | 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
| 2026 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2029 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study aims to examine the relationship between treatment modalities (hearing aids and cochlear implants) and outcomes in patients with moderate-to-severe hearing loss, and to identify predictive factors for the efficacy of these devices.
Management information
Registered date
| 2026 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072084
