UMIN-CTR Clinical Trial

Basic information
Public title	Effects of cochlear implant in patients with unitlateral severe hearing loss and tinnitus
Acronym	Effects of cochlear implant in patients with unilateral hearing loss and tinnitus
Scientific Title	Effects of cochlear implant in patients with unitlateral severe hearing loss and tinnitus
Scientific Title:Acronym	Effects of cochlear implant in patients with unilateral hearing loss and tinnitus
Region	Japan

Condition
Condition	unilateral severe hearing loss and tinnitus
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	evaluate of cochlear implant the patients with unilateral severe hearing loss and tinnitus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	effects of hearing and tinnitus after cochlear implant
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	cochlear implant
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	acquired (severe) hearing loss indicating that higher than 70dBHL(500-2000Hz Audiogram) and less than 30 % speech discrimination.
Key exclusion criteria	post meningitis,anomaly, etc
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kaoru Ogawa
Organization	Keio University, School of Medicine
Division name	Dept Otolarynoglogy
Zip code
Address	35 Shinanomachi Shinjuku
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Sho Kanzaki
Organization	Keio University
Division name	Otolaryngology
Zip code
Address
TEL	03-5363-3827
Homepage URL
Email

Sponsor
Institute	Department of Otolarynoglogy Keio University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Otolaryngology in Shinshu university,and Saiseika Utunomiya hospital
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	慶應義塾大学病院

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 11 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	Completed
Date of protocol fixation	2012 Year 09 Month 06 Day
Date of IRB	2012 Year 06 Month 25 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2015 Year 09 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	2012 Year 09 Month 11 Day
Last modified on	2019 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010413