Effects of Sound Stimulation, Somatosensory Stimulation, Vestibular Stimulation and the Combinations on Tinnitus Loudness and Tinnitus Related Distress in Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Tinnitus disability scale
研究概览
简要总结
In this experiment, patients with chronic pure tone tinnitus were divided into three groups to receive auditory stimulation, somatosensory stimulation, vestibular stimulation and combined stimulation, in order to find an effective way to treat tinnitus
详细描述
120 patients with chronic pure tone tinnitus over 6 months were randomly divided into 6 groups, one group was given auditory stimulation, one group was given somatosensory stimulation, one group was given auditory stimulation + somatosensory stimulation, one group was given auditory stimulation + vestibular stimulation, the last group was given auditory stimulation + somatosensory stimulation + vestibular stimulation.
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, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pure tone tinnitus
- •Unilateral and bilateral
- •female and male
- •Tinnitus has a history of more than 6 months
排除标准
- •Pulsatile tinnitus of blood vessel
- •Meniere's disease
- •Chronic headache
- •Neurological diseases (such as brain tumors)
- •Patients with mental / mental illness undergoing treatment
- •Pregnant women and patients with other untreatable diseases
研究组 & 干预措施
acoustic stimulation
Pink noise in both ears is given to tinnitus patients. The pink noise is removed by notch filter from tinnitus frequencies that are 20 decibel higher than the threshold.
干预措施: multiple sensory stimulation (Device)
somatic stimulation
Three stimulation points were selected for each ear of tinnitus patients, namely ear door (CN.V), auditory Palace (CN.VII) and Yifeng (C2/3). The stimulation intensity should be needle-sensed.
干预措施: multiple sensory stimulation (Device)
vestibular stimulation
The patient sat on a rotating chair with sinusoidal harmonic acceleration and rotated without causing the greatest frequency of discomfort.
干预措施: multiple sensory stimulation (Device)
acoustic + somatic stimulation
Combination of auditory and somatic stimulation for tinnitus patients
干预措施: multiple sensory stimulation (Device)
acoustic + vestibular stimulation
Combination of auditory and vestibular stimulation for tinnitus patients
干预措施: multiple sensory stimulation (Device)
acoustic + somatic + vestibular stimulation
Combination of auditory stimulation, somatic stimulation and vestibular stimulation for tinnitus patients
干预措施: multiple sensory stimulation (Device)
结局指标
主要结局
Tinnitus disability scale
时间窗: Three months from the time the patient was selected to the end of the stimulus
Tinnitus handicap inventory score was used to detect the degree of tinnitus.0-16 points without disability, 18-36 points with mild disability, 38-56 points with moderate disability and 58-100 points with severe disability. The 95% confidence interval is 20 points, that is, the difference between the two tests before and after the experiment is greater than or equal to 20 points.
Electrical audiometry and acoustic impedance
时间窗: Three months from the time the patient was selected to the end of the stimulus
Assessment of hearing in patients
Tinnitus frequency and loudness
时间窗: Three months from the time the patient was selected to the end of the stimulus
Detection of tinnitus frequency and loudness in patients
次要结局
未报告次要终点
研究者
Dan Su
principal investigator
The First Affiliated Hospital of Anhui Medical University