Efficacy of Amplification With Hearing Aids for Tinnitus Relief: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The Tinnitus Functional Index (Chinese version) (TFI-CH)
研究概览
简要总结
This study evaluates the treatment efficacy of tinnitus in people with mild hearing loss. One-third of participants will use hearing aid, one-third of participants will use customized music, while the other one-third participants will receive no treatment (waiting list control).
详细描述
Acoustic stimulation could induce plastic changes in the auditory cortex, and tinnitus mechanisms have been viewed as a negative consequence of neural plasticity in the central nervous system after peripheral aggression. Cortical changes (neural activity in the deafferented cortical area was reduced but the adjacent frequencies of the hearing loss region activated more extensive cortical areas) occur after sensorineural hearing loss, while exposure to an acoustically enriched environment or using hearing aids may minimize or reverse the plastic tonotopic map changes in the auditory cortex. The use of hearing aids in tinnitus management for people with significant hearing loss will always be associated with an improvement in hearing handicap and quality of life, and that complicates the interpretation of how much hearing aids specifically affect tinnitus. Thus studies on tinnitus patients with mild hearing loss could be illuminating, and this population will be targeted in the present study.
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 (Outcomes Assessor)
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
- •18 years old or above
- •can provide written informed consent
- •have a diagnosis of subjective tinnitus, i.e., the tinnitus can only be heard by the patient and there is no acoustic source
- •a tinnitus duration of more than one year
- •have pure-tone average between 20 and 40 dB HL
- •have bilateral symmetrical hearing loss (i.e. difference less than 15 dB)
- •have at least a medium level of distress caused by tinnitus as indicated with total scores above 30 on the TQ-CH
- •are committed to complete the 12-month follow-up
排除标准
- •objective tinnitus, i.e. tinnitus produced by an internal acoustic source activating the cochlea and can be heard by another person
- •received other forms of tinnitus treatments within three months before the baseline assessment session
- •any history suggestive of psychiatric illness
- •psychological distress or depression as indicated with total scores at or above 15 on the Cantonese HADS
- •current hearing aid users
- •inability to complete the study as revealed by the medical reports
结局指标
主要结局
The Tinnitus Functional Index (Chinese version) (TFI-CH)
时间窗: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
TFI-CH is a 25-item self-administered questionnaire which assesses eight domains of tinnitus impact: intrusiveness; sense of control; cognitive; sleep; auditory; relaxation; quality of life (QoL); emotion. The total TFI score ranges 0 - 100, the higher score is indicative of greater problem with tinnitus.
次要结局
- Self-rated Visual Analogue Scale (VAS) on tinnitus loudness(Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.)
- The Chinese Hospital Anxiety and Depression Scale (HADS)(Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.)
- The Tinnitus Questionnaire (Chinese version) (TQ-CH) scores(Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.)
- The Tinnitus Handicap Inventory (Chinese version) (THI-CH) scores(Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.)
- Tinnitus loudness matches at the tinnitus frequency and at 1000 Hz(Change from baseline values at 3 months, 6 months and 12 months after the first day of treatment will be measured.)
研究者
KAM Chi Shan Anna
Associate Professor
Education University of Hong Kong