A randomized controlled trial assessing the effectiveness of hearing aids (intervention setting) compared to hearing aids (placebo setting) in reducing tinnitus for adults with mild hearing loss

Betsi Cadwaladr University Health Board0 个研究点目标入组 16 人开始时间: 2021年6月2日最近更新: 2022年12月5日

适应症

试验速览

暂无简介。

•1. Age 18 years or over with a clinical diagnosis of tinnitus with mild sensorineural hearing loss* unilaterally or bilaterally, hearing level (4FA) measured no more than 6 months prior to tinnitus assessment appointment
•2. Willing to trial hearing aid/s only as a tinnitus management option
•3. Capable of providing written informed consent
•4. Ability to communicate in English
•5. Ability to understand and complete the English versions of the questionnaires
•*For the purposes of this trial, mild hearing loss is defined as hearing threshold between 26 and 40dBHL when averaged at the four frequencies of 0.5, 1, 2 and 4kHz as per the World Health Organisation definition (2019) and other studies (Donahue et al, 2010; Ferguson et al, 2017; Mathers et al, 2000). This measure is referred to in this protocol as 4FA”

•1. Tinnitus of a medically treatable origin
•2. Hearing loss of a medically treatable origin
•3. Unilateral tinnitus reported in the ear with normal hearing
•4. Hearing loss (4FA) of 41dB or greater unilaterally
•5. Those requiring other tinnitus management options
•6. Previous use of a hearing aid, combination device or behind the ear sound generator
•7. GAD-7 score of 8 or more and/or PHQ-9 score of 10 or more, suggesting more complex mental health needs

发起方