UMIN-CTR Clinical Trial

Basic information
Public title	Categorical perception of voiced plosives and speech perception in cochlear implant users.
Acronym	Categorical perception of voiced plosives and speech perception in cochlear implant users.
Scientific Title	Categorical perception of voiced plosives and speech perception in cochlear implant users.
Scientific Title:Acronym	Categorical perception of voiced plosives and speech perception in cochlear implant users.
Region	Japan

Condition
Condition	Congenital severe to profound hearing loss. Cochlear implant user.
Classification by specialty	Oto-rhino-laryngology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate perception of acoustic cues to place of articulation in cochlear implant users who received implant in early childhood.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Results of identification task and discrimination task on synthetic voice. Results of speech perception test.
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	Other
Interventions/Control_1	hearing test
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	11 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Congenital hearing loss. Received cochlear implant in childhood. 10 years over after received implant.
Key exclusion criteria	Progressive hearing loss. Acquired hearing loss. Can understand the test .
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name UEDA
Organization	Shizuoka General Hospital International University of Health and Welfare graduate school master course
Division name	Otolaringology Speech therapy and audiology division
Zip code	420-8527
Address	4-27-1 Aoi-ward, Shizuoka-city, Shizuoka
TEL	054-247-6111
Email	yuko-ueda@i.shizuoka-pho.jp

Public contact
Name of contact person	1st name Yuko Middle name Last name UEDA
Organization	Shizuoka General Hospital/International University of Health and Welfare graduate school master cour
Division name	Otolaringology ,Speech therapy and audiology division
Zip code	420-8527
Address	4-27-1 Aoi-ward, Shizuoka-city, Shizuoka
TEL	0542476111
Homepage URL
Email	yuko-ueda@i.shizuoka-pho.jp

Sponsor
Institute	Shizuoka General Hospital
Institute
Department

Funding Source
Organization	International University of Health and Welfare Graduate School
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	Shizuoka General Hospital Research Ethical Committee
Address	4-27-1 Aoi-ward,Shizuoka-city,Shizuoka
Tel	0542476111
Email	chiken-sougou@shizuoka-pho.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	静岡県立総合病院

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 27 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	45
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	Completed
Date of protocol fixation	2021 Year 08 Month 17 Day
Date of IRB	2021 Year 08 Month 17 Day
Anticipated trial start date	2021 Year 09 Month 27 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 09 Month 25 Day
Last modified on	2022 Year 04 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052020