UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015231 |
|---|---|
| Receipt number | R000006617 |
| Scientific Title | Psychophysiological study in influence of auditory motion perception on adaptation of the vestibulo-ocular reflex |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2016/03/27 19:31:31 |
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Basic information
Public title
Psychophysiological study in influence of auditory motion perception on adaptation of the vestibulo-ocular reflex
Acronym
Auditory influence of adaptation of VOR
Scientific Title
Psychophysiological study in influence of auditory motion perception on adaptation of the vestibulo-ocular reflex
Scientific Title:Acronym
Auditory influence of adaptation of VOR
Region
| Japan |
Condition
Condition
Vestibular dysfunction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Basic study to invent effective rehabilitation methods for vestibular dysfunction.
Basic objectives2
Others
Basic objectives -Others
The influence of auditory stimulus on adaptation of VOR.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of gain and phase in VOR between before and after adaptation.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Adaptation for horizontal vestibular stimulation
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults without any history of neurologic otological symptoms
Key exclusion criteria
Subjects are determined not healthy adults.
Subjects who have confusion in the front-back direction of the sound source, in the listening of the virtual sound source by earphone. Subjects who should not be applied the standard head-related transfer function of the virtual sound source.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Izumi koizuka |
Organization
St. Marianna Uniersity school of medicine
Division name
Department of otorhinolaryngology
Zip code
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki
TEL
044-977-8111
koizuka@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko O. Kato |
Organization
St. Marianna Uniersity school of medicine
Division name
Department of otorhinolaryngology
Zip code
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki
TEL
044-977-8111
Homepage URL
yumiko_o_kato@cwk.zaq.ne.jp
Sponsor or person
Institute
St. Marianna Uniersity school of medicine, department of otorhinolaryngology
Institute
Department
Personal name
Funding Source
Organization
St. Marianna Uniersity school of medicine, department of otorhinolaryngology
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jser/72/3/72_156/_article/-char/ja/
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jser/72/3/72_156/_article/-char/ja/
Number of participants that the trial has enrolled
Results
We examined the changes of the VOR caused by adaptation to a rotating virtual sound source. The gain reduced in the post-adaptation phase when the sound rotated in the opposite direction to head rotation at the same velocity. There was no significant change in the VOR gain associated with adaptation to a sound source rotating the same direction as the head, but at twice the velocity.
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
| 2014 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 24 | Day |
Last modified on
| 2016 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006617
