Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060560) titled 'VR/AR Auditory Training for New Hearing Aid Users' on March 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Gunma University

Condition: Condition - Bilateral Mild-to-Moderate Sensorineural Hearing Loss Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the short-term efficacy and safety of a 12-week VR/AR auditory training program for early-stage hearing aid users. The primary objectives are to evaluate improvements in hearing aid use persistence, speech-in-noise recognition, and subjective benefit. Secondary objectives include assessing safety through the monitoring of cybersickness (e.g., vertigo, nausea) and evaluating program feasibility via completion rates. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - This study implements a VR/AR-based auditory training program for individuals during the initial phase of hearing aid adaptation. The intervention consists of 12 weekly sessions over a 12-week period, with each session lasting approximately 15 minutes. Conducted in a hospital setting under professional supervision, participants use a VR headset to perform speech-in-noise listening tasks in either virtual or augmented reality environments, featuring an automated difficulty adjustment algorithm based on individual performance.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients aged 18 years or older with bilateral mild-to-moderate sensorineural hearing loss (30 dB to <70 dB) who have recently initiated bilateral hearing aid use at the time of enrollment. Participants must be capable of wearing a VR headset, performing the designated rehabilitation program, and providing consent for regular hospital visits and clinical evaluations throughout the study period. Key exclusion criteria - Individuals who have difficulty using VR/AR devices due to severe dizziness, equilibrium disorders, or significant visual impairment. Other exclusion criteria include cognitive decline that impedes the understanding of instructions or performance of tasks, presence of structural ear diseases such as external auditory canal atresia or active cholesteatoma, and any other conditions deemed inappropriate for participation by the principal investigator. Target Size - 12

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 02 Day Date of IRB - 2026 Year 02 Month 02 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2029 Year 06 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069270

Disclaimer: Curated by HT Syndication.