UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016054 |
|---|---|
| Receipt number | R000018660 |
| Scientific Title | Exploratory study on the effect of noisy vestibular stimulation on body balance with long duration |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2019/06/29 14:13:25 |
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Basic information
Public title
Exploratory study on the effect of noisy vestibular stimulation on body balance with long duration
Acronym
Effect of long noisy vestibular stimulation on body balance
Scientific Title
Exploratory study on the effect of noisy vestibular stimulation on body balance with long duration
Scientific Title:Acronym
Effect of long noisy vestibular stimulation on body balance
Region
| Japan |
Condition
Condition
peripheral vestibular dysfunction
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of noisy vesitbular stimulation with long duration on body balance regarding its safety, carry-over effect, and effect of repeated stimulation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
postural balance when standing on a foamrubber with eyes closed
Key secondary outcomes
subjective sense of imbalance when standing on a foamrubber with eye closed
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1st week: vestibular stimulation for 30 minutes
2nd week: vestibular stimulation for 3 hours
Interventions/Control_2
1st week: vestibular stimulation for 3 hours
2nd week: vestibular stimulation for 30 minutes
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy volunteers without history of dizziness, hearing loss or ear diseases.
Key exclusion criteria
1) having metals in the body
2) orthopedic diseases
3) heart disease
4) can't walk without assistance
5) having cancer
6) taking tranquilizer or antidepressants
7) having alcohol after 22 o'clock on the day before testing
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Iwasaki |
Organization
University of Tokyo Hispital
Division name
Department of Otolaryngology
Zip code
167-0043
Address
Tokyo
TEL
+81364547830
iwashin-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yusaburo |
| Middle name | |
| Last name | Uetake |
Organization
University of Tokyo Hospital
Division name
IRB
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358008665
Homepage URL
yuetake-tky@umin.ac.jp
Sponsor or person
Institute
Department of Otolaryngology, Faculty of Medicine, University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
0358008665
u-tokyo@esct.bvits.com
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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 05 | 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
| 2014 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 25 | Day |
Last modified on
| 2019 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018660
