Tokyo, July 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062211) titled 'Preliminary Study on Elucidating the Mechanisms and Establishing Assessment Criteria for Listening Difficulties' on July 13.

Study Type: Interventional

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

Primary Sponsor: Institute - Tohoku University

Condition: Condition - Listening Difficulties Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In our study, we conducted exploratory psychoacoustic and neurophysiological tests on both individuals with normal hearing and those with hearing difficulties in a setting that simulates everyday environments, where audiovisual stimuli were presented. The results will serve as foundational data for future efforts to elucidate the pathophysiology of hearing difficulties and establish intervention and support methods. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants performed a dichotic listening task in which a target stimulus sound was presented to one ear and a distractor stimulus sound to the opposite ear, while a distractor stimulus video was presented via a video display device according to the experimental condition. Using the speech discrimination accuracy for the target stimulus sound and auditory evoked potentials (N100, ASSR)/ event-related potentials (P300, mismatch negativity) obtained from the measurements. We will exploratively examine conditions in which attention to the target stimulus sound is disrupted, differences in measurement results between hearing volunteers and individuals with hearing difficulties (patient volunteers), and the presence or absence of additive effects associated with multisensory integration of the attention-distracting stimulus.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1 No history of ear disorders or neurological conditions 2 Average hearing level in both ears is less than 25 dB HL on puretone audiometry 3 Age 18 years or older, but under 40 years of age at the time of enrollment 4 Gender Open to both men and women 5 Participants who have provided written informed Key exclusion criteria - 1 Individuals with a history of ear disorders 2 Individuals with a history of peripheral or central nervous system disorders 3 Any other individuals deemed unsuitable as study participants by the principal investigator or a co-investigator Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 22 Day Date of IRB - 2026 Year 05 Month 27 Day Anticipated trial start date - 2026 Year 07 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=R000071192

Disclaimer: Curated by HT Syndication.