UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057832 |
|---|---|
| Receipt number | R000065599 |
| Scientific Title | A study of the actual condition of environmental sound listening among the hearing impaired and its use in daily life |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/11/10 13:53:15 |
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Basic information
Public title
A study of the actual condition of environmental sound listening among the hearing impaired and its use in daily life
Acronym
Actual condition of environmental sound listening among the hearing impaired
Scientific Title
A study of the actual condition of environmental sound listening among the hearing impaired and its use in daily life
Scientific Title:Acronym
Actual condition of environmental sound listening among the hearing impaired
Region
| Japan |
Condition
Condition
hearing impairments
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the reality of environmental sound hearing for the hearing impaired
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Individual Factors Psychological Characteristics and Physiological Responses to Environmental Sound Listening in Hearing Impaired Individuals
Key secondary outcomes
Comparison of listening performance of environmental sound identification tests and correlations in questionnaires
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
Hearing aid or cholea implant users
Key exclusion criteria
19 years old and younger and 91 years old and older
Target sample size
100
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
049-276-1296
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
049-276-1296
Homepage URL
takayama.atsuya@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Tsukuba
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
049-276-1354
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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to examine the factors that affect environmental sound listening in hearing-impaired people and to clarify the actual situation of environmental sound listening.
Management information
Registered date
| 2025 | Year | 05 | Month | 11 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065599
