UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046958 |
|---|---|
| Receipt number | R000053502 |
| Scientific Title | The Relationship between Environmental Sound Listening and Acoustic Characteristics in the Deaf and Hard of Hearing |
| Date of disclosure of the study information | 2022/02/22 |
| Last modified on | 2023/05/31 11:03:30 |
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Basic information
Public title
The Relationship between Environmental Sound Listening and Acoustic Characteristics in the Deaf and Hard of Hearing
Acronym
Environmental Sound Perception in Hearing Impaired People
Scientific Title
The Relationship between Environmental Sound Listening and Acoustic Characteristics in the Deaf and Hard of Hearing
Scientific Title:Acronym
Environmental Sound Perception in Hearing Impaired People
Region
| Japan |
Condition
Condition
hearing impairments
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investingated the effect of environmental sound for hearing-impaired person.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Environmental noise listening task
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hearing aid or cholea implant users
Key exclusion criteria
Less than 19 years old and 81 years old or older
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | IKEZONO |
Organization
Saitama Medical University Hospital
Division name
Otolaryngology
Zip code
3500495
Address
38, Morohongo, Moroyama-machi, Iruma-gun, Saitama Pref.
TEL
049-276-1296
saitamakikoe@gmail.com
Public contact
Name of contact person
| 1st name | Atsuya |
| Middle name | |
| Last name | Takayama |
Organization
Saitama Medical University Hospital
Division name
Otolaryngology
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
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
| 2022 | Year | 02 | Month | 22 | 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
26
Results
Results date posted
| 2023 | Year | 05 | Month | 31 | Day |
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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | 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 clarify the problems and characteristics of environmental sound perception in an environmental sound listening task for hearing impaired people who wear hearing aids, and to collect basic data on the state of environmental sound perception in daily life.
Management information
Registered date
| 2022 | Year | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053502
