UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023214 |
|---|---|
| Receipt number | 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 17:14:53 |
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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
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
hhiraumi@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026648
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
