Different Stimuli Were Given to Patients With Chronic Pure Tone Tinnitus to Verify the Effective Treatment of Tinnitus.

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effects of Sound Stimulation, Somatosensory Stimulation, Vestibular Stimulation and the Combinations on Tinnitus Loudness and Tinnitus Related Distress in Patients

Conditions
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Tinnitus, Acoustic Stimulation, Somatic Stimulation, Vestibular Stimulation

Intervention / Treatment
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* Device: multiple sensory stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pure tone tinnitus Unilateral and bilateral female and male Tinnitus has a history of more than 6 months Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acoustic stimulation<br>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. | Device: multiple sensory stimulation<br>* The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested. Then the patients were randomly divided into six groups. They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks. After the last stimulation, the above tests were repeated immediately, one week later and three months later.<br>|
| Experimental: somatic stimulation<br>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. | Device: multiple sensory stimulation<br>* The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested. Then the patients were randomly divided into six groups. They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks. After the last stimulation, the above tests were repeated immediately, one week later and three months later.<br>|
| Experimental: vestibular stimulation<br>The patient sat on a rotating chair with sinusoidal harmonic acceleration and rotated without causing the greatest frequency of discomfort. | Device: multiple sensory stimulation<br>* The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested. Then the patients were randomly divided into six groups. They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks. After the last stimulation, the above tests were repeated immediately, one week later and three months later.<br>|
| Experimental: acoustic + somatic stimulation<br>Combination of auditory and somatic stimulation for tinnitus patients | Device: multiple sensory stimulation<br>* The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested. Then the patients were randomly divided into six groups. They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks. After the last stimulation, the above tests were repeated immediately, one week later and three months later.<br>|
| Experimental: acoustic + vestibular stimulation<br>Combination of auditory and vestibular stimulation for tinnitus patients | Device: multiple sensory stimulation<br>* The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested. Then the patients were randomly divided into six groups. They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks. After the last stimulation, the above tests were repeated immediately, one week later and three months later.<br>|
| Experimental: acoustic + somatic + vestibular stimulation<br>Combination of auditory stimulation, somatic stimulation and vestibular stimulation for tinnitus patients | Device: multiple sensory stimulation<br>* The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested. Then the patients were randomly divided into six groups. They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks. After the last stimulation, the above tests were repeated immediately, one week later and three months later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrical audiometry and acoustic impedance | Assessment of hearing in patients | Three months from the time the patient was selected to the end of the stimulus | 
| Tinnitus frequency and loudness | Detection of tinnitus frequency and loudness in patients | Three months from the time the patient was selected to the end of the stimulus | 
| Tinnitus disability scale | 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. | Three months from the time the patient was selected to the end of the stimulus | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus, stimulation