UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of accent on words cognition of cochlear implant patients
Title of the study (Brief title)	Effect of accent on words cognition of cochlear implant patients
Region	Japan

Condition
Condition	Hearing impairment
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	When presenting the same word with two kinds of standard language and Kansai dialect, it is confirmed whether there is a difference in correct answer rate of hearing. From this, it is aimed to confirm that the rehabilitation with the term most frequently mentioned by the cochlear implant patients is optimal, and increase the efficiency of training. In addition, because the words hearing test (evaluation of how accurately the speech is being heard) regularly checking the cochlear implant patients has been recorded in the standard language, the future of this examination is considered.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate correct answer ratio of words hearing test after cochlear implantation.
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Speech discrimination test will be done.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	In cochlear implant patients who visit our department of otorhinolaryngology, subjects with a correct answer rate of 30% or more in the words hearing test are targeted.
Key exclusion criteria	Exclude those who have experience live in the Kansai region.
Target sample size	30

Research contact person
Name of lead principal investigator	Sho Kanzaki
Organization	Keio University School of Medicine
Division name	Otorhinolaryngology
Address	35 Shinanomachi,Sinjuku-ku,Tokyo,160-8582,JAPAN
TEL	03-3353-1211
Email	skan@keio.jp

Public contact
Name of contact person	Azusa Maegawa
Organization	Keio University School of Medicine
Division name	Otorhinolaryngology
Address	35 Shinanomachi,Sinjuku-ku,Tokyo,160-8582,JAPAN
TEL	03-3353-1211
Homepage URL
Email	azusa.maegawa@adst.keio.ac.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	None
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	2017 Year 03 Month 09 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 03 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 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	2017 Year 03 Month 07 Day
Last modified on	2017 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030388