UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Auditory evoked brain activity
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Takao Imai
Organization	Osaka University Graduate School of Medicine
Division name	Otorhinolaryngology - Head and Neck Surgery
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3951
Email	timai@ent.med.osaka-u.ac.jp

Public contact
Name of contact person	Takao Imai
Organization	Osaka University Graduate School of Medicine
Division name	Otorhinolaryngology - Head and Neck Surgery
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3951
Homepage URL
Email	timai@ent.med.osaka-u.ac.jp

Sponsor
Institute	Department of Otorhinolaryngology, Osaka University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 09 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012259