The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- THI
研究概览
简要总结
The University of Sao Paulo Department of Otorhinolaryngology developed prototypes for a digital new hearing aid with an integrated sound generator. These prototypes assist both hearing rehabilitation (about 10% of the population) and tinnitus sufferers (about 17% of the population).
Currently, the Brazilian Public Heath Care does not have any such hearing aids. So, the development of devices for the hearing rehabilitation as well as the treatment of tinnitus represents an advance in the implementation of Public Policies in Brazil.
The aim of this study is to compare the efficacy of the hearing aid with an integrated sound generator and amplification alone for tinnitus control in patients with tinnitus associated hearing loss.
详细描述
This study, in the form of a blind randomized clinical trial, was approved by CAPPesq under protocol number: 0163/10.
49 adults with tinnitus and sensorineural hearing loss were randomly assigned into 2 groups. Both groups received counseling about tinnitus. One group received hearing aids with only amplification and the other group received hearing aids with an integrated sound generator. After the fitting process, both groups were told to use the hearing devices 8 hours per day. The outcome measures as the tinnitus handicap inventory and psychoacoustics measurements were conducted by a blind audiologist that didn't know each group each patient belonged to.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mild to moderate sensorineural hearing loss
- •tinnitus (THI > 20)
- •first user
排除标准
- •profound hearing loss
- •conductive hearing loss
- •THI < 20
结局指标
主要结局
THI
时间窗: 3 months
tinnitus handicap inventory
次要结局
未报告次要终点
研究者
Gisele Munhoes dos Santos
PhD
University of Sao Paulo