UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043997 |
|---|---|
| Receipt number | R000050247 |
| Scientific Title | Basic research of the effect on sound localization by bilateral hearing aid fitting |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2021/04/21 12:42:46 |
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Basic information
Public title
Basic research of the effect of bilateral hearing aid fitting
Acronym
The effect of bilateral hearing aid fitting
Scientific Title
Basic research of the effect on sound localization by bilateral hearing aid fitting
Scientific Title:Acronym
Basic research of the effect of bilateral hearing aid fitting
Region
| Japan |
Condition
Condition
hearing loss
Classification by specialty
| Oto-rhino-laryngology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of bilateral hearing aid fitting
Basic objectives2
Others
Basic objectives -Others
To investigate the effect on sound localization by bilateral hearing aid fitting
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The ratio of correct answer of sound localization
Key secondary outcomes
The characteristics of output sound from hearing aid
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
hearing test with recorded sound resource
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
subjects without ear diseases
Key exclusion criteria
subjects with ear diseases
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Sano |
Organization
Kitasato university
Division name
school of allied health sciences
Zip code
2520373
Address
1-15-1 Kitasato Minamiku Sagamihara Kanagawa, Japan
TEL
0427788111
sanohj@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | HAJIME |
| Middle name | |
| Last name | SANO |
Organization
Kitasato university
Division name
school of allied health sciences
Zip code
2520373
Address
1-15-1 Kitasato Minamiku Sagamiara Kanagawa, Japan
TEL
+819012581001
Homepage URL
sanohj@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato university
Institute
Department
Personal name
Funding Source
Organization
Kitasato university
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
review board of Kitasato university, school of allied health sciences
Address
1-15-1 Kitasato Minamiku Sagamihara Kanagawa, Japan
Tel
0427789602
inouek@kitasato-u.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
| 2021 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | 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
| 2021 | Year | 04 | Month | 21 | Day |
Last modified on
| 2021 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050247
