UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059434 |
|---|---|
| Receipt number | R000067972 |
| Scientific Title | A Study on the Diagnostic Accuracy of a Dizziness Testing Device Using VR Goggles |
| Date of disclosure of the study information | 2025/10/17 |
| Last modified on | 2025/10/16 17:43:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study on the Diagnostic Accuracy of a Dizziness Testing Device Using VR Goggles
Acronym
A Study on the Diagnostic Accuracy of a Dizziness Testing Device Using VR Goggles
Scientific Title
A Study on the Diagnostic Accuracy of a Dizziness Testing Device Using VR Goggles
Scientific Title:Acronym
A Study on the Diagnostic Accuracy of a Dizziness Testing Device Using VR Goggles
Region
| Japan |
Condition
Condition
Dizziness,Vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to simultaneously perform detailed equillibrium texaminations using electro-nystagmography (ENG) and those using VR goggles on both a normal population and a group of patients with vertigo, and to compare the data from both groups in order to clarify the diagnostic accuracy of the VR goggle-based testing.
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to simultaneously perform detailed equillibrium texaminations using electro-nystagmography (ENG) and those using VR goggles on both a normal population and a group of patients with vertigo, and to compare the data from both groups in order to clarify the diagnostic accuracy of the VR goggle-based testing.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(i) Optokinetic nystagmus test: maximum slow phase velocity of nystagmus during optokinetic stimulation.
(ii) Caloric test: maximum slow phase velocity of nystagmus and rate of fixation suppression during four stimulation conditions (right ear cold stimulation, right ear warm stimulation, left ear cold stimulation and left ear warm stimulation).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Optokinetic stimuli (alternating black and white stripes presented in front of the eyes in a sitting position are accelerated at 1 degree/sec2 to the right or left and the participants are instructed to watch the stripes moving in front of their eyes as much as possible, accelerating up to 100 degrees/sec and recording the OKN seen during the acceleration).
Interventions/Control_2
Caloric vestibular stimulation test (a test to observe nystagmus induced by injecting warm water (or warm air) or cold water (or cold air) into the external auditory canal at 30 degrees supine position).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-dizziness subject group: adult subjects aged 18 years and over with no history of ear disease (otitis media, perforated tympanic membrane, etc.), hearing loss, or dizziness/imbalance disorder.
Dizziness patient group: Dizziness patients who attended the Advanced Vertigo Centre of Toyama University Hospital with a chief complaint of vertigo or dizziness and were diagnosed with peripheral vestibular disorder or central disequilibrium disorder (or suspected).
Key exclusion criteria
1 Persons with complications that may seriously interfere with the conduct of the study (interstitial pneumonia, pulmonary fibrosis, severe emphysema, uncontrolled diabetes or hypertension, history of myocardial infarction within 3 months, uncontrolled angina pectoris or irregular heartbeat, etc., heart failure, liver failure, renal failure, peptic ulcer, etc.)
2 Women who are pregnant, lactating or intend to become pregnant during the study period.
3 Those with a history of hospital visits or medication for psychiatric disorders.
4 Any other person who is judged by the principal investigator to be inappropriate as a subject for this study, including
a.Persons who are judged to have poor comprehension of the instructions and requests of the researchers
b.Persons who are judged to be uncooperative in responding to the instructions and requests of the researchers
c.Others
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Takakura |
Organization
Toyama University Hospital
Division name
Department of Otorhinolaryngology, Head and Neck surgery
Zip code
930-0194
Address
Sugitani 2630, Toyama city, Toyama
TEL
076-434-2281
hiromasa@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Takakura |
Organization
Toyama University Hospital
Division name
Department of Otolrhinolaryngology, Head and Neck surgery
Zip code
930-0194
Address
Sugitani2630, Toyama-city, Toyama
TEL
076-434-2281
Homepage URL
hiromasa@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Department of Otorhinolaryngology, Head and Neck surgery, University of Toyama
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical and Translational Research, Toyama University Hospital
Address
Sugitani 2630, Toyama-city, Toyama
Tel
076-434-2281
rinri@adm.u-toyama.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
| 2025 | Year | 10 | Month | 17 | 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
| 2025 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067972
