UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060740 |
|---|---|
| Receipt number | R000069497 |
| Scientific Title | Everyday Use of Environmental Sounds in the Lives of People with Hearing Impairments |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/02/24 18:27:24 |
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Basic information
Public title
Use of Environmental Sounds in the Daily Lives of People with Hearing Impairments: A Questionnaire-Based Survey
Acronym
Use of Environmental Sounds in the Daily Lives of People with Hearing Impairments: A Questionnaire-Based Survey
Scientific Title
Everyday Use of Environmental Sounds in the Lives of People with Hearing Impairments
Scientific Title:Acronym
Everyday Use of Environmental Sounds in the Lives of People with Hearing Impairments
Region
| Japan |
Condition
Condition
Hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the perceived everyday use of environmental sounds among people with hearing impairments through a questionnaire survey.
Basic objectives2
Others
Basic objectives -Others
To examine the relationship between questionnaire scores and accuracy on an environmental sound identification task.
In addition, to examine the associations between individual factors (e.g., age, hearing thresholds, speech perception ability, duration of device use, and duration of hearing loss) and questionnaire outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analyze the subjective evaluations derived from questionnaire responses regarding environmental sound listening ability among people with hearing impairments.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Case Groups
HA Group: Cases wearing hearing aids
CI Group: Cases wearing cochlear implants
Control Groups
Young Adult Group Cases with uncorrected hearing thresholds below 20 dB
Cases aged 20 to under 40 years
Students enrolled at the University of Tsukuba who provided informed consent to participate in the study
Elderly Group Cases with unamplified hearing thresholds below 30 dB
Cases aged 60 years or older but under 90 years
Individuals enrolled at the Narita City Silver Human Resources Center who provided informed consent to participate in the study
Key exclusion criteria
Participants with congenital hearing impairment who have difficulty engaging in spoken-language conversation
Participants with MMSE scores below the cutoff value
Younger group
Participants with unaided hearing thresholds 20 dB
Participants with a current otologic disorder
Older group
Participants with unaided hearing thresholds 30 dB
Participants with a current otologic disorder
Target sample size
120
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
0492761111
admin@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
埼玉県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | 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 | 07 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2026 | Year | 02 | Month | 24 | Day |
Last modified on
| 2026 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069497
