Broadband Amplification as Tinnitus Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Tinnitus Handicap Inventory
研究概览
简要总结
- The effect of broadband amplification was tested in a double-blinded crossover study
- Its effect was compared to an active placebo treatment
- An improvement in tinnitus distress was found after use of broadband amplification
- No effect was found on the tinnitus loudness
详细描述
This study investigated the effect of broadband amplification (125 Hz to 10 kHz) as tinnitus treatment for participants with high-frequency hearing loss and compared these effects with an active placebo condition using band-limited amplification (125 Hz to 3-4 kHz). A double-blinded crossover study. 23 participants with a high-frequency (≥ 3 kHz) hearing loss and chronic tinnitus were included in the study and 17 completed the full treatment protocol. Two different hearing aid treatments were provided for 3 months each: broadband amplification that provided gain in the frequency range from 125 Hz to 10 kHz and band-limited amplification that only provided gain in the low frequency range (≤ 3-4 kHz). The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI) questionnaires. The effect of the treatment on tinnitus loudness was evaluated with a visual analog scale (VAS) for loudness and a psychoacoustic loudness measure. Furthermore, the tinnitus annoyance was evaluated with a VAS for annoyance. The tinnitus pitch was evaluated based on the tinnitus likeness spectrum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic tinnitus
- •hearing thresholds (<=25 dB HL) up to 2000 Hz and hearing loss at frequencies above 2 kHz
- •inexperienced hearing aid user
排除标准
- •objective or pulsatile tinnitus
- •Ménière's disease, otosclerosis, stapedectomy, stapedotomy or tympanoplasty
结局指标
主要结局
Tinnitus Handicap Inventory
时间窗: 3 months
Questionnaire assessing tinnitus related distress. 25 questions that can be answered with yes(4 points), sometimes (2 points), no (0 points)
Tinnitus Functional Index
时间窗: 3 months
Questionnaire assessing tinnitus related distress. 25 questions that can be answered with likert scale from 0-10 (or 0-100%) where 10 is the most extreme negative value
次要结局
- Visual Analog Scale - annoyance(3 months)
- Visual Analog Scale - loudness(3 months)
- Tinnitus loudness(3 months)
- Tinnitus spectrum(3 months)
研究者
Mie Joergensen
PhD student
Technical University of Denmark