UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060956 |
|---|---|
| Receipt number | R000069529 |
| Scientific Title | Improvement effects on environmental sound perception in individuals with hearing loss |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/02/27 08:29:40 |
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Basic information
Public title
Investigation of the improvement effects on environmental sound perception in individuals with hearing loss
Acronym
Investigation of improvement effects on environmental sound perception
Scientific Title
Improvement effects on environmental sound perception in individuals with hearing loss
Scientific Title:Acronym
Improvement effects on environmental sound perception in individuals with hearing loss
Region
| Japan |
Condition
Condition
Hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine, in individuals with hearing loss, the effects of hearing-device use and environmental-sound training on improvements in environmental sound perception, by evaluating changes in environmental-sound perception performance and subjective ratings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the magnitude of improvement in the percent correct on an environmental-sound identification task and in questionnaire scores before and after hearing-device use, as well as following environmental-sound listening training.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants in the HA group will be individuals with no prior experience of wearing hearing aids.
Interventions/Control_2
Participants will be individuals who have used hearing aids or cochlear implants for at least one year (at least 1 year since fitting or activation).
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Study 1: Participants in the HA group will be individuals with no prior experience of wearing hearing aids.
Study 2: Participants will be individuals who have used hearing aids or cochlear implants for at least one year (1 year since fitting/activation).
Key exclusion criteria
Individuals deemed ineligible for participation by the principal investigator, a physician, or a speech-language-hearing therapist.
Individuals with congenital hearing impairment who have difficulty engaging in spoken-language conversation.
Individuals with MMSE scores at or below the cutoff (i.e., below the cutoff score).
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsuya |
| Middle name | |
| Last name | Takayama |
Organization
Saitama Medical University Hospital
Division name
Otorhinolaryngology/Neuro-Otology
Zip code
3500495
Address
38, Morohongo, Moroyama-machi, Iruma-gun, Saitama Pref.
TEL
0492761111
takayama.atsuya@1972.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Astuya |
| Middle name | |
| Last name | Takayama |
Organization
Saitama Medical University Hospital
Division name
Otorhinolaryngology/Neuro-Otology
Zip code
3500495
Address
38, Morohongo, Moroyama-machi, Iruma-gun, Saitama Pref.
TEL
0492761111
Homepage URL
takayama.atsuya@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Takayama Atsuya
Funding Source
Organization
Saitama Medical University Hospital
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
Saitama Medical University Hospital Clinical Research Center Hospital IRB Office
Address
38, Morohongo, Moroyama-machi, Iruma-gun, Saitama Pref
Tel
0492761354
hirb@saitama-med.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 | 06 | 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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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 | 03 | Month | 17 | Day |
Last modified on
| 2026 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069529
