UMIN-CTR Clinical Trial

Basic information
Public title	Creating a visual stimulator
Acronym	Creating a visual stimulator
Scientific Title	Creating a visual stimulator using a head-mounted display (HMD)
Scientific Title:Acronym	Creating a visual stimulator using HMD
Region	Japan

Condition
Condition	Vestibular disorder
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Seasickness and virtual reality sickness are known to cause equilibrium dysfunction due to a "mismatch" between somatosensory (mainly through skin and muscle sensation) and visual sensations, but it is known to become accustomed (adaptation). Responses adapted by somatosensory or visual sensations are referred to as adaptive phenomena, which we examined using rotation testing and a flat and spherical screen with projected black and white stripes, as well as visual vestibular inconsistency stimulation. The results of our previous studies showed that a flat screen under off-vertical axis rotation (OVAR) and a spherical screen under earth vertical axis rotation (EVAR) were suitable for visual vestibular inconsistency stimulation. Visual stimulation of linear motion was suitable for otolith-ocular reflex (OOR) and visual stimulation of rotational angular rate motion for semicircular canal-ocular reflex (ScOR). The purpose of this study is to reaffirm previous research by using computer graphic techniques to perform pseudo-linear and pseudo-rotational visual stimuli. The eventual goal is to obtain the basic data necessary to appropriately select the modality of visual stimulation to be used during rehabilitation, depending on the site of the disorder, in cases where the semicircular canal is impaired or the otolith is impaired.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Using the created HMD, perform pseudo-linear and pseudo-rotational visual stimulation on the subject. Subjects will be asked to complete a questionnaire immediately following the study. Evaluate the validity of the stimuli by asking the participants to describe whether they feel as if they moved reality in a straight line when they experienced the pseudo-linear visual stimuli, and whether they feel as if they rotated reality when they experienced the pseudo-rotational visual stimuli ("felt", "felt a little", or "did not feel").
Key secondary outcomes	Using the created HMD, perform pseudo-linear and pseudo-rotational visual stimulation on the subject. Subjects will be asked to complete a questionnaire immediately following the study. The participants will be asked to describe whether nausea or other symptoms appeared during the test ("felt", "felt a little", or "did not feel") to evaluate safety.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The participants will wear a head-mounted display (HMD). Pseudo-linear and pseudo-rotational visual stimuli are added on the HMD, and the visibility is verified by a questionnaire method. The test time is approximately 30 minutes. The test will be conducted only once per subject.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy subjects who do not have an equilibrium disorder and who have given their free and voluntary written consent to participate in this study, after having demonstrated sufficient understanding of the study after the explanation of the study.
Key exclusion criteria	Cases in which consent was not obtained, and other cases in which participation in the study was deemed impossible due to medical conditions or physical condition.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Izumi Middle name Last name Koizuka
Organization	St. Marianna University School of Medicine
Division name	Otorhinolaryngology
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL	044-977-8111(ext.3261)
Email	koizuka@marianna-u.ac.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Ito
Organization	St. Marianna University School of Medicine
Division name	Otorhinolaryngology
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL	044-977-8111(ext.3261)
Homepage URL
Email	yusuke.ito@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagashima Medical Instruments.Co.,Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	St. Marianna University School of Medicine
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
Tel	044-977-8111
Email	k-sienbu.mail@marianna-u.ac.jp

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	2022 Year 10 Month 18 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	Preinitiation
Date of protocol fixation	2022 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date	2022 Year 10 Month 18 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 10 Month 18 Day
Last modified on	2022 Year 10 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056017