UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060560 |
|---|---|
| Receipt number | R000069270 |
| Scientific Title | Short-term Efficacy and Safety of VR/AR-based Auditory Training During the Initial Phase of Hearing Aid Adaptation |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/03 11:21:48 |
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Basic information
Public title
VR/AR Auditory Training for New Hearing Aid Users
Acronym
VR/AR Auditory Rehabilitation
Scientific Title
Short-term Efficacy and Safety of VR/AR-based Auditory Training During the Initial Phase of Hearing Aid Adaptation
Scientific Title:Acronym
Efficacy & Safety of VR/AR Auditory Training
Region
| Japan |
Condition
Condition
Bilateral Mild-to-Moderate Sensorineural Hearing Loss
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the short-term efficacy and safety of a 12-week VR/AR auditory training program for early-stage hearing aid users. The primary objectives are to evaluate improvements in hearing aid use persistence, speech-in-noise recognition, and subjective benefit. Secondary objectives include assessing safety through the monitoring of cybersickness (e.g., vertigo, nausea) and evaluating program feasibility via completion rates.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hearing aid continuation rate at 3 months after the start of intervention
Key secondary outcomes
Speech perception in noise (J-Matrix) at 3 months after the start of intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
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
This study implements a VR/AR-based auditory training program for individuals during the initial phase of hearing aid adaptation. The intervention consists of 12 weekly sessions over a 12-week period, with each session lasting approximately 15 minutes. Conducted in a hospital setting under professional supervision, participants use a VR headset to perform speech-in-noise listening tasks in either virtual or augmented reality environments, featuring an automated difficulty adjustment algorithm based on individual performance.
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
Patients aged 18 years or older with bilateral mild-to-moderate sensorineural hearing loss (30 dB to <70 dB) who have recently initiated bilateral hearing aid use at the time of enrollment. Participants must be capable of wearing a VR headset, performing the designated rehabilitation program, and providing consent for regular hospital visits and clinical evaluations throughout the study period.
Key exclusion criteria
Individuals who have difficulty using VR/AR devices due to severe dizziness, equilibrium disorders, or significant visual impairment. Other exclusion criteria include cognitive decline that impedes the understanding of instructions or performance of tasks, presence of structural ear diseases such as external auditory canal atresia or active cholesteatoma, and any other conditions deemed inappropriate for participation by the principal investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | MASAOMI |
| Middle name | |
| Last name | MOTEGI |
Organization
Gunma University Hospital
Division name
Otolaryngology-Head and Neck Surgery
Zip code
371-8511
Address
3-39-15 Showamachi, Maebashi, Gunma, Japan
TEL
0272207111
m_motegi@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | MASAOMI |
| Middle name | |
| Last name | MOTEGI |
Organization
Gunma University Hospital
Division name
Otolaryngology-Head and Neck Surgery
Zip code
371-8511
Address
3-39-15 Showamachi, Maebashi, Gunma, Japan
TEL
0272207111
Homepage URL
m_motegi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Motegi, Masaomi
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showamachi, Maebashi, Gunma, Japan
Tel
0272207111
imrc-jimu@ml.gunma-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
Gunma
Institutions
Institutions
群馬大学医学部附属病院（群馬県） 羽生総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | 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
| 2026 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 01 | 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 | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069270
