UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025120 |
|---|---|
| Receipt number | 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 | 2021/01/28 13:54:09 |
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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 | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7303
kawase@orl.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7303
Homepage URL
kawase@orl.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo-machi, Aoba-ku
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2016 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
12
Results
Twelve subjects (24 ears) with normal hearing were examined auditory function tests such as speech intelligibility testing under noise, and normal values for subjects with normal hearing were evaluated.
Results date posted
| 2021 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
normal volunteer
Participant flow
Open call for participants
Adverse events
none
Outcome measures
speech intelligibility in noise
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
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
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028883
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
