UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062394 |
|---|---|
| Receipt number | R000071406 |
| Scientific Title | Feasibility and Pre-Post Speech-in-Noise Outcomes of Smartphone Application-Based Auditory Training in Adults with Hearing Loss: A Prospective Single-Arm Study |
| Date of disclosure of the study information | 2026/07/29 |
| Last modified on | 2026/07/29 20:45:26 |
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Basic information
Public title
A study of smartphone-based auditory training and listening in noise in adults with hearing loss
Acronym
Smartphone Auditory Training Study
Scientific Title
Feasibility and Pre-Post Speech-in-Noise Outcomes of Smartphone Application-Based Auditory Training in Adults with Hearing Loss: A Prospective Single-Arm Study
Scientific Title:Acronym
App-Based Auditory Training Study
Region
| Japan |
Condition
Condition
Hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Many individuals with hearing loss experience difficulty understanding speech in noisy environments. As no established treatment is currently available, interventions to improve speech-in-noise ability are needed. This study aims to evaluate whether auditory training using a smartphone application improves speech-in-noise ability.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes from baseline to after 3 months of auditory training in the speech reception threshold corresponding to 50% correct responses (SRT50) on the digits-in-noise test (DIN) and digits-in-two-talker-babble test (DI2TB).
Key secondary outcomes
Changes from baseline to after the intervention in pure-tone audiometry, speech audiometry, and self-reported listening difficulties assessed using a questionnaire.
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
A three-month auditory training program performed for 30 minutes daily using a smartphone application
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants were required to meet all of the following criteria:
1. Normal pure-tone hearing with self-reported difficulty understanding speech in noise that interfered with daily life, or mild-to-moderate hearing loss
2. Daily smartphone use
3. Reduced speech-in-noise performance confirmed by screening testing
Key exclusion criteria
Participants with markedly insufficient training time or duration.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Suda |
Organization
Keio University School of Medicine
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3827
s.sudamed@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Suda |
Organization
Keio University School of Medicine
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3827
Homepage URL
s.sudamed@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Satoshi Suda
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
OTO Clinic Tokyo Ethics Committee
Address
1-30-8 Sendagaya, Shibuya-ku, Tokyo, Japan
Tel
03-5363-3827
oishin@keio.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 | 07 | Month | 29 | 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
23
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 02 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071406
