Effects of Acoustic Stimulation Techniques on Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Short-term tinnitus loudness suppression
研究概览
简要总结
This study compared tinnitus suppression after 3-minute and 20-minute acoustic stimulation using an individually optimized stimulus. In total 45 tinnitus patients participated. Thirty-three participants with chronic subjective tinnitus completed three sessions. During the first two sessions, eight individualized filtered and modulated stimuli were presented for 3 minutes each to identify the stimulus inducing the strongest tinnitus suppression. This stimulus was subsequently applied for 20 minutes in the third session.
详细描述
The study comprised three experimental acoustic stimulation sessions. In session one, audiometric and tinnitometric assessments were conducted, followed by stimulation with three noise stimuli: white noise (WN), white noise with a bandstop filter (WN_BS), and white noise with a bandpass filter (WN_BP), each implemented with a one-octave filter around the individual tinnitus frequency (ITF). Session two (3-14 days later) included five pure tone stimuli: a tone at the ITF, two amplitude-modulated tones at the ITF (10 Hz, 23 Hz), and two amplitude-modulated tones three octaves below the ITF (10 Hz, 23 Hz). Stimuli were presented diotically for 3 minutes with 1000 ms fade-in/out, separated by 6-minute breaks. Participants experiencing brief acoustic tinnitus suppression (BATS) in session one or two completed a third session, in which the stimulus inducing the strongest suppression was applied for 20 minutes. Tinnitus loudness was rated immediately after stimulation using a numeric rating scale (0-110% of baseline loudness) at multiple time points up to 180 seconds, and up to 600 seconds after the 20-minute stimulation to capture prolonged suppression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic tinnitus, defined as a tinnitus duration of at least 6 months
- •Written informed consent: The patient must be able to understand the study information, comply with the required examinations and appointments, and provide written informed consent
- •Male or female patients, aged 18-75 years
排除标准
- •Objective tinnitus
- •Tinnitus below 1000 Hz
- •Presence of Menière's disease, otosclerosis, acoustic neuroma, or other clearly identifiable and treatable causes of tinnitus
- •Initiation of other tinnitus treatments within the last three months prior to study entry
- •Lack of informed consent
- •Oropharyngeal infection
- •Presence of clinically relevant severe internal, neurological, or psychiatric disorders
- •Drug, medication, or alcohol abuse within 12 weeks prior to study entry
- •Any other condition that, in the opinion of the investigator, makes participation in the study unsuitable
- •Hyperacusis
- •Current pharmacological treatment with psychoactive substances (e.g., antidepressants, anticonvulsants)
研究组 & 干预措施
Acoustic stimulation with individual best stimulus - 20 minutes
Acoustic stimulation - 20 minutes
干预措施: Acoustic Stimulation - 20 minutes (Other)
Acoustic stimulation with individual best stimulus - 3 minutes
Acoustic stimulation - 3 minutes
干预措施: Acoustic stimulation - 3 minutes (Other)
结局指标
主要结局
Short-term tinnitus loudness suppression
时间窗: From immediately after acoustic stimulation until 180 seconds post-stimulation. start: immediately after stimulation end: 180 seconds post-stimulation
Tinnitus loudness ratings are obtained immediately after each acoustic stimulation application at seven time points (every 30 seconds: t0, t30, t60, t90, t120, t150, and t180) using a numeric rating scale ranging from 0-110%. A rating of 100% indicates tinnitus loudness equal to the pre-stimulation level, values above 100% indicate increased loudness, and values below 100% indicate reduced loudness.
次要结局
未报告次要终点
研究者
Berthold Langguth, MD, Ph.D.
Prof. Dr. Berthold Langguth
University of Regensburg