UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study on auditory evoked field in patients with auditory processing disorders
Acronym	Auditory evoked field in patients with auditory processing disorders
Scientific Title	Exploratory study on auditory evoked field in patients with auditory processing disorders
Scientific Title:Acronym	Auditory evoked field in patients with auditory processing disorders
Region	Japan

Condition
Condition	auditory processing disorders
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To visualize the pathophysiology of auditory function in patients with auditory processing disorders using magnetoencephalography
Basic objectives2	Others
Basic objectives -Others	Establishment of objective evaluation
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	latency of N100m
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	magnetoencephalography
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	40 years-old >
Gender	Male and Female
Key inclusion criteria	a) age: 20 years old or older than 20 years, and younger than 40 years old b)performance status = 0
Key exclusion criteria	1) Subjects using a pacemaker and/or an implantable defibrillator 2) Subjects with the metals in the body 3) Subjects with scotophobia and/or claustrophobia 4) Subjects with the possibility of the pregnancy 5) Subjects with extreme myopia 6) Subjects who wear clothing (e.g., heat technical centers) for the cold protection using the new material 7) Subjects whom researchers judged to be inappropriate
Target sample size	30

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	the Ministry of Education, Culture, Sports, Science and Technology-Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2017 Year 07 Month 27 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 07 Month 27 Day
Date of IRB
Anticipated trial start date	2017 Year 08 Month 01 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	2017 Year 07 Month 27 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=R000032523

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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