Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063094) titled 'Exploratory study on factors predicting the effectiveness of cochlear implants and hearing aids' on Sept. 30.
Study Type:
Observational
Primary Sponsor:
Institute - Keio University
Condition:
Condition - Sensorineural hearing loss
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The relationship between treatment methods (hearing aids, cochlear implants) and prognosis in patients with moderate to severe hearing loss is examined.
Basic objectives2 - Bio-availability
Eligibility:
Age-lower limit - 55
years-old
Gender - Male and Female
Key inclusion criteria - Cases of sensorineural hearing loss meeting the following criteria and seeking new treatment with hearing aids or cochlear implants:
(1) Aged 55 to 84 years
(2) Bilateral sensorineural hearing loss confirmed by pure-tone audiometry
(3) Pure-tone hearing threshold of the better-hearing ear between 40 dB HL and 90 dB HL (inclusive of 40, exclusive of 90)
(4) Maximum speech intelligibility score of the better-hearing ear is 60% or less
(5) Consent to participate in this study has been obtained
Key exclusion criteria - (1) Patients who have already received appropriate treatment with hearing aids or cochlear implants, and for whom no additional treatment is required
(2) Patients with otologic conditions unsuitable for hearing aids or cochlear implants
(3) Patients already diagnosed with dementia
(4) Other cases deemed inappropriate for study participation by investigator(s)
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 14 Day
Date of IRB - 2026 Year 08 Month 31 Day
Anticipated trial start date - 2026 Year 09 Month 30 Day
Last follow-up date - 2029 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072084
Disclaimer: Curated by HT Syndication.
