UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058567 |
|---|---|
| Receipt number | R000066963 |
| Scientific Title | A Study on the Development of a Telemedicine System for Speech and Language Rehabilitation by Speech-Language Pathologists for Cochlear Implant and Hearing Aid Users |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2025/07/23 18:26:53 |
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Basic information
Public title
A Study on the Development of a Telemedicine System for Speech and Language Rehabilitation by Speech-Language Pathologists for Cochlear Implant and Hearing Aid Users
Acronym
A Study on the Development of a Telemedicine System for Speech and Language Rehabilitation by Speech-Language Pathologists for Cochlear Implant and Hearing Aid Users
Scientific Title
A Study on the Development of a Telemedicine System for Speech and Language Rehabilitation by Speech-Language Pathologists for Cochlear Implant and Hearing Aid Users
Scientific Title:Acronym
A Study on the Development of a Telemedicine System for Speech and Language Rehabilitation by Speech-Language Pathologists for Cochlear Implant and Hearing Aid Users
Region
| Japan |
Condition
Condition
hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For individuals with hearing impairment using cochlear implants or hearing aids, rehabilitation - including mapping and fitting - is essential for maintaining optimal auditory function. However, a shortage of professionals and medical institutions imposes a significant burden on users and their families due to the necessity of frequent clinic visits. In Western countries, telemedicine for people with hearing impairment has become increasingly widespread. In Japan as well, the utility and safety of telemedicine have been demonstrated to some extent through a Ministry of Health, Labour and Welfare scientific research project initiated in fiscal year 2022. Moving forward, further studies are required to achieve social implementation of such services, including rehabilitation.
This study aims to acquire the knowledge necessary for social implementation of telemedicine services for individuals with hearing impairment through operational practice and validation. By addressing regional disparities, reducing patient burdens, and promoting effective use of specialized resources, we seek to establish a telemedicine support system for cochlear implant and hearing aid users with a view toward future insurance coverage. Ultimately, this initiative is expected to improve healthcare access and the quality of rehabilitation for people with hearing impairment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hearing performance of users under telemedicine and in-person care (monosyllabic word recognition test in quiet: 67S at 60 dBHL; aided threshold test; and, where available, word recognition test in quiet: CI2004 at 65 dBSPL and word recognition test in noise: CI2004 at 65 dBSPL with SNR +10 dB)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Combining telemedicine with face-to-face services (mapping and speech rehabilitation)
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Selection Criteria for Telemedicine in Cochlear Implant Users]
Patients who have been using their cochlear implant(s) for 12 months or more (aged 6 years or older)
Patients with either unilateral or bilateral cochlear implants
Patients using cochlear implants compatible with telemedicine
Patients whose mapping, created during face-to-face care within 6 months prior to the start of this study, is stable
[Selection Criteria for Family Members or Caregivers of Cochlear Implant Users and Hearing Aid Users]
Accompany the patient during telemedicine sessions
Aged 18 years or older
[Selection Criteria for Remote Speech Rehabilitation]
Elementary school children who wish to receive articulation training
Patients using either unilateral or bilateral cochlear implants or hearing aids
Patients using cochlear implants or hearing aids compatible with telemedicine
Key exclusion criteria
Patients who decline to participate in this study
Patients whom the investigators consider inappropriate as study subjects due to complications, treatment progress, or other reasons
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Takano |
Organization
Sapporo Medical University
Division name
Department of Otolaryngology Head and Neck Surgery
Zip code
060-8556
Address
Minami 1-jo Nishi 17-chome, Chuo-ku, Sapporo,Hokkaido
TEL
011-611-2111
kent@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Sumito |
| Middle name | |
| Last name | Jitsukawa |
Organization
Sapporo Medical University
Division name
Department of Otolaryngology Head and Neck Surgery
Zip code
060-8556
Address
Minami 1-jo Nishi 17-chome, Chuo-ku, Sapporo,Hokkaido
TEL
011-611-2111
Homepage URL
sumitojjj@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
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
nstitutional Review Board (IRB), Sapporo Medical University
Address
Minami 1-jo Nishi 17-chome, Chuo-ku, Sapporo,Hokkaido
Tel
011-611-2111
ji-rskk@sapmed.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 | 07 | Month | 31 | 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
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2029 | 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 | 07 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066963
