Tokyo, July 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058567) titled 'A Study on the Development of a Telemedicine System for Speech and Language Rehabilitation by Speech-Language Pathologists for Cochlear Implant and Hearing Aid Users' on July 31.

Study Type: Interventional

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

Primary Sponsor: Institute - Sapporo Medical University

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

Objective: Narrative objectives1 - For individuals with hearing impairment using cochlear implants or hearing aids, rehabilitation - including mapping and fitting - is essential for maintaining optimal auditory function. However, a shortage of professionals and medical institutions imposes a significant burden on users and their families due to the necessity of frequent clinic visits. In Western countries, telemedicine for people with hearing impairment has become increasingly widespread. In Japan as well, the utility and safety of telemedicine have been demonstrated to some extent through a Ministry of Health, Labour and Welfare scientific research project initiated in fiscal year 2022. Moving forward, further studies are required to achieve social implementation of such services, including rehabilitation. This study aims to acquire the knowledge necessary for social implementation of telemedicine services for individuals with hearing impairment through operational practice and validation. By addressing regional disparities, reducing patient burdens, and promoting effective use of specialized resources, we seek to establish a telemedicine support system for cochlear implant and hearing aid users with a view toward future insurance coverage. Ultimately, this initiative is expected to improve healthcare access and the quality of rehabilitation for people with hearing impairment. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Combining telemedicine with face-to-face services (mapping and speech rehabilitation)

Eligibility: Age-lower limit - 6 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - [Selection Criteria for Telemedicine in Cochlear Implant Users] Patients who have been using their cochlear implant(s) for 12 months or more (aged 6 years or older) Patients with either unilateral or bilateral cochlear implants Patients using cochlear implants compatible with telemedicine Patients whose mapping, created during face-to-face care within 6 months prior to the start of this study, is stable

[Selection Criteria for Family Members or Caregivers of Cochlear Implant Users and Hearing Aid Users] Accompany the patient during telemedicine sessions Aged 18 years or older

[Selection Criteria for Remote Speech Rehabilitation] Elementary school children who wish to receive articulation training Patients using either unilateral or bilateral cochlear implants or hearing aids Patients using cochlear implants or hearing aids compatible with telemedicine Key exclusion criteria - Patients who decline to participate in this study Patients whom the investigators consider inappropriate as study subjects due to complications, treatment progress, or other reasons Target Size - 210

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 06 Month 12 Day Date of IRB - 2025 Year 06 Month 12 Day Anticipated trial start date - 2025 Year 06 Month 12 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=R000066963

Disclaimer: Curated by HT Syndication.