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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023214
Receipt No. R000026648
Scientific Title Effects of the auditory space on balance in cochlear implantation patients
Date of disclosure of the study information 2016/09/10
Last modified on 2019/01/20

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Basic information
Public title Effects of the auditory space on balance in cochlear implantation patients
Acronym CI and balance
Scientific Title Effects of the auditory space on balance in cochlear implantation patients
Scientific Title:Acronym CI and balance
Region
Japan

Condition
Condition Cochlear implantation recipients
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the auditory space recognition on balance function in cochlear implant patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To see the effect of CI activation on the postulography in various sound condition and various CI condition.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
4 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria CI recipients attending Iwate Medical University
Key exclusion criteria Those who cannot tolerate the postulography
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Harukazu Hiraumi
Organization Iwate Medical University
Division name Otolaryngology, Head and Neck Surgery
Zip code
Address 19-1, Uchimaru, Morioka
TEL 019-651-5111
Email hhiraumi@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Harukazu Hiraumi
Organization Iwate Medical University
Division name Otolaryngology, Head and Neck Surgery
Zip code
Address 19-1, Uchimaru, Morioka
TEL 019-651-5111
Homepage URL
Email hhiraumi@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization Iwate Medical University
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 09 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/?term=oikawa+k%2C+hiraumi+h
Number of participants that the trial has enrolled
Results
In CI subjects, sound stimulation improves the abnormal displacement of COP in the mediolateral direction.
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
2016 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 10 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 08 Month 30 Day

Other
Other related information To explore the body balance function by using a postulography in cochlear implant recipients in a normal room and an anechoic room

Management information
Registered date
2016 Year 07 Month 18 Day
Last modified on
2019 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026648

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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