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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043997
Receipt No. 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

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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
Email 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
Email sanohj@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050247

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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