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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025120
Receipt No. R000028883
Scientific Title Hearing function under the noise -evaluation in normal volunteer-
Date of disclosure of the study information 2016/12/02
Last modified on 2018/06/11

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Basic information
Public title Hearing function under the noise -evaluation in normal volunteer-
Acronym Hearing function under the noise -evaluation in normal volunteer-
Scientific Title Hearing function under the noise -evaluation in normal volunteer-
Scientific Title:Acronym Hearing function under the noise -evaluation in normal volunteer-
Region
Japan

Condition
Condition normal function
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of the normal range concerning the hearing function in noise to evaluate the hearing difficulty of the person with hearing loss
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes speech intelligibility
Key secondary outcomes

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
Device,equipment
Interventions/Control_1 auditory function
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
40 years-old >
Gender Male and Female
Key inclusion criteria normal volunteer (20 <= age < 40, and the performance status=0)
Key exclusion criteria 1) past history of peripheral and/or central neurologic disease
2) past history of ear disease
3) past history of mental disease
4) Pacemaker and/or implanted defibrillator
5) cerebral aneurysm clip, a bolt and a plate after the bone fracture treatment, the correction of the tooth, tattoo, hairdye for less than one month
6) claustrophobia, scotophobia
7) the possible pregnancy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuaki kawase
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7303
Email kawase@orl.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuaki kawase
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7303
Homepage URL
Email kawase@orl.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku 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
Address
Tel
Email

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
2016 Year 12 Month 02 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
2016 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 02 Day
Last modified on
2018 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028883

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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