Study on the Effect of Sound Therapy on Chronic Primary Tinnitus
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Tinnitus Handicap Inventory ( THI)
研究概览
简要总结
This study is to compare the effect of Cochleural Alternating Acoustic Beam Therapy(CAABT) and tinnitus masking therapy(TMT) on chronic primary tinnitus.Half of participants will receive CAABT, while the other half will receive TMT.
详细描述
The patients with tinnitus will be collected with medical history, ear examination ,auditory function test and questionnaire survey.100 cases of chronic primary tinnitus will be selected as the research object.This study will be developed in the form of a blind randomized clinical trial.The study subjects will be divided into 2 groups by randomized method, with 50 cases in each group. Psychological acoustic test, Resting-state function magnetic resonance imaging（RS-fMRI) will be conducted.For 6 months, the patients will be treated with Cochleural Alternating Acoustic Beam Therapy（CAABT）and tinnitus masking therapy（TMT） respectively, followed by questionnaire survey, psychological acoustics test and RS-fMRI. The THI,VAS score, RS-fMRI ReHo value and low-frequency wave amplitude (ALFF) before and after the treatment will be compared. For those cases with poor results, the exchanged treatment will be performed for 6 months, followed by questionnaire survey, psychoacoustic test, RS-fMRI, and comparison of THI, VAS score, ReHo value and ALFF before and after treatment.All cases will be followed up for 1 year, and questionnaire survey will be conducted again.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Ages between 18-75 years
- •Tinnitus undergone for more than 6 months
- •Continuous attack, single tone dominated, annoying tinnitus
- •Able to cooperate with auditory function test and psychoacoustic test
- •The main tinnitus frequency is from 125Hz to 8000Hz
- •Willing to use the equipment daily during the test
- •Willing and able to follow up regularly
- •Ability to read and write Chinese, able to understand and complete questionnaires
排除标准
- •Secondary tinnitus
- •Pure tone audiometry shows conduction deafness or mixed deafness
- •Tinnitus main frequency threshold >60dB
- •Receiving treatment for other tinnitus
- •MRI contraindications
- •Feeling uncomfortable with the treatment equipment or not being accepted
研究组 & 干预措施
CAABT
CAABT(Cochleural Alternating Acoustic Beam Therapy) is an innovative tinnitus intervention which based on neural science and cochlear plastic research and aimed to reprogram the central auditory system to neutralize the discordant responses of the dysfunctioning cochlea via acoustic beaming stimuli.
干预措施: CAABT (Device)
TMT
TMT(tinnitus masking therapy) is a traditional tinnitus intervention. The masking sound is mainly white noise, and the intensity just covers tinnitus.
干预措施: TMT (Device)
结局指标
主要结局
Tinnitus Handicap Inventory ( THI)
时间窗: baseline, 2 months, 4 months, 6 months
Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Tinnitus Handicap Inventory scale. Efficacy evaluation criteria: (1) cure: THI score was reduced to less than 16 points;(2) significant effect: THI score decreased by more than 17 points;(3) invalid: THI score value decreased \< 17 points or even increased.Efficiency is the sum of cure and effect.
Resting-state function magnetic resonance imaging(RS-fMRI) low-frequency wave amplitude (ALFF)
时间窗: baseline, 6 months
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ALFF
Resting-state function magnetic resonance imaging(RS-fMRI) Regional homogeneity(ReHo) value
时间窗: baseline, 6 months
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ReHo value
Visual Analogue Scale(VAS)
时间窗: baseline, 2 months, 4 months, 6 months
Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Visual Analogue Scale(VAS). The number 0 to 10 indicates the severity of symptoms, "0" means no symptoms, and "10" means the most severe
次要结局
未报告次要终点
研究者
Shu-sheng Gong
director of Department of Otorhinolaryngology Head and Neck Surgery
Beijing Friendship Hospital