UMIN-CTR Clinical Trial

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
Email	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
Email	yuetake-tky@umin.ac.jp

Sponsor
Institute	Department of Otolaryngology, Faculty of Medicine, University of Tokyo
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018660