Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060956) titled 'Investigation of the improvement effects on environmental sound perception in individuals with hearing loss' on June 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Saitama Medical University Hospital

Condition: Condition - Hearing loss Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine, in individuals with hearing loss, the effects of hearing-device use and environmental-sound training on improvements in environmental sound perception, by evaluating changes in environmental-sound perception performance and subjective ratings. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants in the HA group will be individuals with no prior experience of wearing hearing aids. Interventions/Control_2 - Participants will be individuals who have used hearing aids or cochlear implants for at least one year (at least 1 year since fitting or activation).

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Study 1: Participants in the HA group will be individuals with no prior experience of wearing hearing aids.

Study 2: Participants will be individuals who have used hearing aids or cochlear implants for at least one year (1 year since fitting/activation). Key exclusion criteria - Individuals deemed ineligible for participation by the principal investigator, a physician, or a speech-language-hearing therapist.

Individuals with congenital hearing impairment who have difficulty engaging in spoken-language conversation.

Individuals with MMSE scores at or below the cutoff (i.e., below the cutoff score). Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 01 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069529

Disclaimer: Curated by HT Syndication.