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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032019
Receipt No. R000036540
Scientific Title Spatial Hearing in bilateral Cochlear implants
Date of disclosure of the study information 2018/08/01
Last modified on 2019/03/31

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Basic information
Public title Spatial Hearing in bilateral Cochlear implants
Acronym Spatial Hearing in bilateral Cochlear implants
Scientific Title Spatial Hearing in bilateral Cochlear implants
Scientific Title:Acronym Spatial Hearing in bilateral Cochlear implants
Region
Japan

Condition
Condition bilateral sensorineural hearing loss
Classification by specialty
Clinical immunology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate binaural sensitivity, spatial hearing and speech intelligibility under conditions with varying control of binaural cues to assess how well we can restore binaural cues or improve performance with CI processors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The goal of the studies in this protocol
is to provide information about bilateral use of CI.
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 Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Audioligy 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
8 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Subjects will be adults (age 18+) who (a) have received or are scheduled to receive one or more cochlear implants in order to be able to hear, (b) have undergone or are scheduled to undergo corrective surgery to restore hearing, or (c) who wear hearing aids. Subjects who have one cochlear implant for single-sided deafness will have no more than mild to moderate hearing loss in the non-implanted ear. Subjects will have no other known disability, and will primarily use oral language.
Key exclusion criteria People who do not use oral language will be excluded. Individuals who have a cochlear implant, hearing aid, or surgical correction in only one ear may be excluded from this study if the other ear has more than moderate hearing loss. Individuals who have cochlear implants made by manufacturers other than Cochlear Corporation or Advanced Bionics will not participate in experiments in Objective 1, as our lab currently has research platforms provided only by those two manufacturers. The research platforms are only compatible with cochlear implants manufactured by the providing company.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Tadao
Middle name
Last name Yoshida
Organization Nagoya University Graduate School of Medicine
Division name Department of Otorhinolaryngology
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2323
Email tadaoy@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Tadao
Middle name
Last name Yoshida
Organization Nagoya University Graduate School of Medicine
Division name Department of Otorhinolaryngology
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2323
Homepage URL
Email tadaoy@med.nagoya-u.ac.jp

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

Funding Source
Organization Nagoya University Graduate School of Medicine, Department of Otorhinolaryngology
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 Department of Ethics Review Committee
Address 65 Tsurumai-cho, Showa-ku, Nagoya
Tel 052-741-2111
Email ethics@med.nagoya-u.ac.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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
2018 Year 08 Month 01 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2021 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 30 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036540

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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