UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063054 |
|---|---|
| Receipt number | R000072174 |
| Scientific Title | Feasibility of a multidisciplinary telemedicine model for hearing loss and hearing aid guidance using hearing aid specialty stores as remote sites: a prospective, single-arm, exploratory interventional study |
| Date of disclosure of the study information | 2026/10/25 |
| Last modified on | 2026/09/25 16:09:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A prospective interventional study on the feasibility of remote hearing care and hearing aid guidance using hearing aid specialty stores as remote sites
Acronym
Remote hearing aid care feasibility study
Scientific Title
Feasibility of a multidisciplinary telemedicine model for hearing loss and hearing aid guidance using hearing aid specialty stores as remote sites: a prospective, single-arm, exploratory interventional study
Scientific Title:Acronym
Feasibility study of remote hearing aid care using hearing aid stores as remote sites
Region
| Japan |
Condition
Condition
Hearing loss (patients using, trialing, or considering hearing aids)
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of a remote hearing care and hearing aid guidance system in which otolaryngologists/certified hearing aid consultant physicians at Kyoto University Hospital use Webex to review hearing aid use, provide fitting guidance, and determine the need for hospital visits, with certified hearing aid technicians and, when needed, speech-language-hearing therapists present at hearing aid specialty stores serving as remote sites.
Basic objectives2
Others
Basic objectives -Others
feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Session completion rate of remote hearing aid care/guidance sessions (proportion of sessions in which identity confirmation, consent confirmation, Webex connection, presentation of hearing aid information, physician review of hearing aid use, fitting guidance, determination of the need for hospital visits, and post-session documentation were all completed)
Key secondary outcomes
Patient satisfaction; satisfaction of physicians, speech-language-hearing therapists, and certified hearing aid technicians; change in daily hearing aid use time; change in hearing aid benefit; number of changes in fitting plans; number of cases judged to require hospital visits; change in travel burden (travel time, distance, and cost); number of communication problems; number of privacy, conflict-of-interest, and safety incidents; operational issues identified from recordings and transcripts
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
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Remote hearing aid care and guidance via Webex (approximately 1 to 3 sessions per participant, 30 to 60 minutes per session, up to about twice a month). A certified hearing aid technician is present at the remote site (e.g., Ishitsubo Co., Ltd. Fukuchiyama store), with a speech-language-hearing therapist present as needed. Otolaryngologists/certified hearing aid consultant physicians at Kyoto University Hospital perform the following:
(1) Problem identification: assessment of problems with hearing aid use based on the participant's hearing complaints, hearing aid model, settings and fitting history, data logging (daily use time), and audiometric results.
(2) Advice and guidance on hearing aid use: advice to the participant on how, how long, and in what situations to use hearing aids, and guidance to the certified hearing aid technician on fitting adjustments.
(3) Determination of the need for an otolaryngology visit: when physical examination, further testing, or treatment is judged necessary, an in-person visit to Kyoto University Hospital or a nearby medical institution is recommended.
Sessions are audio/video recorded and transcribed as needed. Physical examination, prescriptions, procedures, and preparation of medical documents are not performed during remote sessions.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Aged 18 years or older
2) Patients with hearing loss who are using, trialing, or considering hearing aids
3) Able to receive remote hearing aid care/guidance via Webex at a remote site such as Ishitsubo Co., Ltd. Fukuchiyama store or Fukuchiyama City Hearing and Speech Disability Center
4) Able to understand the study and provide written informed consent, including consent to audio/video recording and transcription
Key exclusion criteria
1) Patients with acute symptoms such as sudden hearing loss, otalgia, otorrhea, or vertigo, or suspected acute disease
2) Patients judged by a physician to require immediate physical examination (e.g., tympanic membrane or ear canal findings)
3) Patients who do not consent to Webex connection, the presence of accompanying staff at the remote site, or audio/video recording and transcription
4) Others judged inappropriate by the principal investigator or attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | HIROSHI |
| Middle name | |
| Last name | YAMAZAKI |
Organization
Kyoto University Hospital
Division name
Integrated Clinical Education center (concurrent: Department of Otolaryngology-Head and Neck Surgery)
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto city
TEL
075-751-3346
inq@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROSHI |
| Middle name | |
| Last name | YAMAZAKI |
Organization
Kyoto University Hospital
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto city
TEL
075751-33
Homepage URL
inq@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Otorhinolaryngology-Head and Neck Surgery
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-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
| 2026 | Year | 10 | Month | 25 | 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 | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | 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
| 2026 | Year | 09 | Month | 25 | Day |
Last modified on
| 2026 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072174
