Tokyo, Oct. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059434) titled 'A Study on the Diagnostic Accuracy of a Dizziness Testing Device Using VR Goggles' on Oct. 17.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - University of Toyama

Condition: Condition - Dizziness,Vertigo Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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).

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 Size - 120

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067972

Disclaimer: Curated by HT Syndication.