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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGTinnitus Handicap Inventory ( THI)
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.
Time frame: baseline, 2 months, 4 months, 6 months
Resting-state function magnetic resonance imaging(RS-fMRI) Regional homogeneity(ReHo) value
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ReHo value
Time frame: baseline, 6 months
Resting-state function magnetic resonance imaging(RS-fMRI) low-frequency wave amplitude (ALFF)
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ALFF
Time frame: baseline, 6 months
Visual Analogue Scale(VAS)
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
Time frame: baseline, 2 months, 4 months, 6 months
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