UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041197 |
|---|---|
| Receipt number | R000046694 |
| Scientific Title | Survey of actual conditions for the hearing impaired and examination of the usefulness of intervention with new hearing aid or speech to text, voice recognition technology |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2024/07/25 09:36:12 |
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Basic information
Public title
Survey of actual conditions for the hearing impaired and examination of the usefulness of intervention with new hearing aid or speech to text, voice recognition technology
Acronym
Survey of actual conditions for the hearing impaired and the usefulness of intervention with hearing aid or voice recognition technology
Scientific Title
Survey of actual conditions for the hearing impaired and examination of the usefulness of intervention with new hearing aid or speech to text, voice recognition technology
Scientific Title:Acronym
Survey of actual conditions for the hearing impaired and the usefulness of intervention with hearing aid or voice recognition technology
Region
| Japan |
Condition
Condition
hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.Assess the difficulty of the hearing impaired
2.Verify the improvement of QOL and the improvement of understanding and processing speed of information by intervention with new hearing aid or speech to text, voice recognition
3.Verify the significance of hearing aid for people with unilateral hearing impaired
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hearing Environments and Reflection on Quality of Life (HEAR-QL-28)
Hearing Handicap Inventory for Adults(HHIA)
Communication Profile for the Hearing Impaired (CPHI)
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
new hearing aid
speech to text voice recognition technology
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
bilateral hearing loss
unilateral hearing loss
auditory processing disorder
Key exclusion criteria
none
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Kataoka |
Organization
Okayama University Hospital
Division name
Otorhinolaryngology
Zip code
700-8558
Address
2-5-1 Shikata-Cho Kitaku Okayama City
TEL
086-235-7307
yu-kat@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Kataoka |
Organization
Okayama University Hospital
Division name
Otorhinolaryngology
Zip code
700-8558
Address
2-5-1 Shikata-Cho Kitaku Okayama City
TEL
086-235-7307
Homepage URL
yu-kat@cc.okayama-u.ac.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Okayama University Hospital
Address
2-5-1 Shikata-Cho Kitaku Okayama City
Tel
086-235-7307
jibika@cc.okayama-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
| 2020 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://okayama.bvits.com/esct/Apply/show.aspx?TYPE=0&ID=14741
Publication of results
Unpublished
Result
URL related to results and publications
https://okayama.bvits.com/esct/Apply/show.aspx?TYPE=6&ID=23728
Number of participants that the trial has enrolled
4
Results
Efficacy
The usefulness was low in general situations, so the study was not continued.
Safety
No special notes
Ethical guidelines compliance status
No particular issues
Other
A trial of voice-to-text conversion showed low effectiveness, and participants felt that there was little point in using it, so the study was discontinued. (Number of discontinuations: 4)
Results date posted
| 2024 | Year | 07 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
people with severe to profound hearing loss
Participant flow
The four subjects expressed a desire to use the speech-to-text device in general situations, especially in meetings. However, when they tried it out, they found it to be of little use. As a result, the study was discontinued.
Adverse events
none
Outcome measures
none
Plan to share IPD
none
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 07 | Month | 22 | Day |
Last modified on
| 2024 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046694
