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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name