Cochleural Alternating Acoustic Beam Therapy Versus Masking Intervention for Tinnitus: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in Tinnitus Subjective Measures at 12 weeks: tinnitus loudness
研究概览
简要总结
This study is to compare the effectiveness of CAABT and masking therapy in the management of subjective tinnitus in adults.Half of participants will receive CAABT, while the other half will receive masking therapy.
详细描述
Masking intervention was a standard monophone tinnitus masking therapy. It was usually a narrow-band noise matched with tinnitus frequency (Tf).
CAABT was 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.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral tinnitus
- •Ages between 18-80 years
- •Tinnitus undergone for more than 6 months
- •Hearing loss of the tinnitus ear not affect communication
- •The main tinnitus frequency is less than 8 KHz
- •Primary tinnitus
排除标准
- •Secondary tinnitus
- •Hyperacusis
- •Patients were accepting any therapy about tinnitus
- •Those who have serious mental illness
- •Patients who can't fit the audiological examination and tinnitus tests
- •Most of the hearing loss in the middle and severe hearing loss of the tinnitus ear
- •Any MRI contraindications
研究组 & 干预措施
masking therapy
Masking intervention was a standard monophone tinnitus masking therapy.
干预措施: masking therapy (Device)
CAABT
CAABT was 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)
结局指标
主要结局
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: tinnitus loudness
时间窗: baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: minimize masking level
时间窗: baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Visual Analog Scale
时间窗: baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: pure tone audiometry
时间窗: baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Chinese version of Tinnitus Handicap Inventory scale
时间窗: baseline and 12 weeks
次要结局
- Change from Baseline in Tinnitus Objective Measure at 12 weeks: functional magnetic resonance imaging (fMRI)(baseline and 12 weeks)
研究者
Shu-sheng Gong
director
Beijing Friendship Hospital