Clinical Trial: Safety and feasibility of repeated dynamic subjective visual vertical (D-SVV) testing using a head-mounted display in healthy adults: a three-condition, three-period, six-sequence randomized crossover study including exploratory evaluation of the effects of auditory and vibrotactile feedback on spatial orientation measures under visual stimulation (Japan)

Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062809) titled 'A study on the safety and feasibility of repeated virtual reality-based testing of the perception of vertical in healthy adults, and on the effects of sound and vibration feedback' on Oct. 1.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Tokushima University

Condition: Condition - Healthy adults (participants with any disease are excluded). The intended future clinical application is chronic dizziness, visually induced dizziness, and vestibular hypofunction. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective is to confirm the safety and the feasibility of repeated dynamic subjective visual vertical (D-SVV) testing using a head-mounted display in healthy adults. The secondary objective is to explore, in comparison with a no-feedback condition, the effects of auditory feedback alone and of combined auditory and vibrotactile feedback during D-SVV on measures of spatial orientation, namely Spatial Visual Susceptibility (SVS) and Postural Visual Susceptibility (PVS). This study is not intended to verify a training effect of sensory feedback. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Condition A (no neurofeedback). Participants wear a head-mounted display (HMD) and undergo 18 trials of dynamic subjective visual vertical (D-SVV) testing while standing on a posturography platform. Each trial lasts approximately 20 seconds, with a 1-minute rest after every 6 trials. The 18 trials comprise combinations of three rotation speeds (10, 20 and 30 degrees/second), two rotation directions (clockwise and counterclockwise) and three starting angles of the rod (-20,-40,-60,+20, +40, +60 degrees). While viewing the rotating visual stimulus, participants adjust the rod to the direction they perceive as vertical. In this condition, neither vibrotactile feedback to the mandible via a tilt perception adjustment device (TPAD) nor auditory feedback via earphones is provided; this condition serves as the control for changes attributable to repeated D-SVV testing itself. In each period, static subjective visual vertical (S-SVV), D-SVV and foam posturography are performed without any feedback before the condition, immediately after the condition, and 30 minutes after the condition. An interval of at least 24 hours is set between periods. Interventions/Control_2 - Condition B (auditory feedback alone). The procedure is the same as in Intervention 1: participants wear an HMD and undergo 18 D-SVV trials while standing on a posturography platform (approximately 20 seconds per trial, with a 1-minute rest after every 6 trials). In this condition, an intermittent tone is presented through commercially available earphones according to the rod angle, only during the 18 D-SVV trials. A higher pitch is presented for a larger absolute rod angle, with a frequency range of 200-2000 Hz and a stepwise correspondence to the angle. The direction of deviation (clockwise or counterclockwise) is distinguished by presenting the tone to the left or right ear. No tone is presented when the absolute rod angle is 0.5 degrees or less. The sound pressure level is limited to 50 dB SPL and adjusted to a level that each participant finds comfortable. The tone is presented only from the start of rod adjustment until the participant confirms the response in each trial. No vibrotactile feedback via TPAD is provided. S-SVV, D-SVV and foam posturography performed before the condition, immediately after the condition, and 30 minutes after the condition are carried out without any feedback.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1)Men and women aged 18 to 65 years 2)Healthy adults 3)Persons who have received an explanation of the study and have provided written informed consent of their own free will Key exclusion criteria - 1)Persons with a past history of vertigo or balance disorder in whom vestibular hypofunction is suspected 2)Persons with current vertigo, unsteadiness, nausea, headache or similar symptoms that are judged to make D-SVV testing difficult 3)Persons judged by the principal investigator or a sub-investigator to have visual impairment, a history of photosensitive epilepsy, hearing impairment, neurological disease, musculoskeletal disease or any other disease that would affect the evaluation of the study data or safety 4)Persons who are pregnant or who may be pregnant 5)Persons otherwise judged by the principal investigator or a sub-investigator to be unsuitable for participation in this study Target Size - 36

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 01 Day Anticipated trial start date - 2027 Year 01 Month 05 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071904

Disclaimer: Curated by HT Syndication.