UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049246 |
|---|---|
| Receipt number | R000056017 |
| Scientific Title | Creating a visual stimulator using a head-mounted display (HMD) |
| Date of disclosure of the study information | 2022/10/18 |
| Last modified on | 2022/10/18 15:25:41 |
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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)
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
yusuke.ito@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056017
