UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010682 |
|---|---|
| Receipt number | R000012259 |
| Scientific Title | Auditory evoked brain activity |
| Date of disclosure of the study information | 2013/05/10 |
| Last modified on | 2016/05/09 19:06:45 |
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Basic information
Public title
Auditory evoked brain activity
Acronym
Auditory evoked brain activity
Scientific Title
Auditory evoked brain activity
Scientific Title:Acronym
Auditory evoked brain activity
Region
| Japan |
Condition
Condition
normal volunteer
Classification by specialty
| Oto-rhino-laryngology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure auditory evoked brain activity using MEG.
Basic objectives2
Others
Basic objectives -Others
To study the influence of sound to human cognitive function.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The data of MEG
Key secondary outcomes
The response to sound
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Subjects are measured their brain activity by MEG about 1 hour.
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
Normal volunteer without hearing problem
Key exclusion criteria
Refuse the approval
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Imai |
Organization
Osaka University Graduate School of Medicine
Division name
Otorhinolaryngology - Head and Neck Surgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3951
timai@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Imai |
Organization
Osaka University Graduate School of Medicine
Division name
Otorhinolaryngology - Head and Neck Surgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3951
Homepage URL
timai@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
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
| 2013 | Year | 05 | Month | 10 | 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
| 2012 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 30 | 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
| 2013 | Year | 05 | Month | 09 | Day |
Last modified on
| 2016 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012259
