UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057229 |
|---|---|
| Receipt number | R000065378 |
| Scientific Title | Evaluation of the Effectiveness of the Japanese Version of the ACE Program for Improving the Psychological and Social Impact of Hearing Loss |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/03/06 19:10:39 |
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Basic information
Public title
Evaluation of the Effectiveness of the Japanese Version of the ACE Program for Improving the Psychological and Social Impact of Hearing Loss
Acronym
Evaluation of the Effectiveness of the Japanese Version of the ACE Program for Improving the Psychological and Social Impact of Hearing Loss
Scientific Title
Evaluation of the Effectiveness of the Japanese Version of the ACE Program for Improving the Psychological and Social Impact of Hearing Loss
Scientific Title:Acronym
Evaluation of the Effectiveness of the Japanese Version of the ACE Program for Improving the Psychological and Social Impact of Hearing Loss
Region
| Japan |
Condition
Condition
hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to demonstrate the effectiveness of the Japanese version of the ACE program for people with hearing loss. It is a group program from Australia designed for non-users of hearing aids and those who are not satisfied with their hearing aid use, and it has been reported to significantly improve psychosocial aspects such as feelings of inferiority and reduced social activity among people with hearing loss. The applicant has created a Japanese version of this program. If its effectiveness is demonstrated in Japan, where most treatments for hearing loss rely solely on hearing aid use, it may become a new treatment option.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function test results, quality of life, hearing, and depression/anxiety questionnaire results six months after participating in the ACE program.
Key secondary outcomes
Questionnaire results on quality of life, hearing, depression/anxiety three weeks after participating in the ACE program.
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
Five program interventions, once a week, for a maximum of two hours each time
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. People with hearing loss who do not wish to use hearing aids or are not satisfied with their hearing aid use.
2. Family members or friends of those who meet condition 1, who are willing to participate at the request of the individual.
3. Individuals who have received a sufficient explanation about this study and have provided written consent of their own free will.
Key exclusion criteria
1. Individuals with acute-onset hearing loss.
2. Individuals with a severe mental disorder.
3. Individuals with moderate or severe dementia (Mini-Mental State Examination score below 24).
4. Others deemed inappropriate by the researchers.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | TOSHIHIDE |
| Middle name | |
| Last name | INAGI |
Organization
Tokai University
Division name
Otolaryngology, Head and Neck Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
TEL
0463-93-1121
318397@tokai.ac.jp
Public contact
Name of contact person
| 1st name | TOSHIHIDE |
| Middle name | |
| Last name | INAGI |
Organization
Tokai University
Division name
Otorhinolaryngology, Head & Neck Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
TEL
0463-93-1121
Homepage URL
318397@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Aichi Medical University, Nagoya University, Okayama University, Gunma University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokai University School of Medicine
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
Tel
0463-93-1121
tokai-rec@tokai.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 | 05 | Month | 01 | 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 | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | 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
| 2025 | Year | 03 | Month | 06 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065378
