Tinnitus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICECAABT
The sound generators with CAABT will be used 15 min each session, three times a day
DEVICETMT
The sound generators with TMT will be used 15 min each session, three times a day
Sponsors
Beijing Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tinnitus Handicap Inventory ( THI) | 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) Regional homogeneity(ReHo) value | baseline, 6 months | Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ReHo value |
| Resting-state function magnetic resonance imaging(RS-fMRI) low-frequency wave amplitude (ALFF) | baseline, 6 months | Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ALFF |
| Visual Analogue Scale(VAS) | 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 |
Countries
China
Contacts
Primary ContactShu-Sheng Gong, MD
Outcome results
None listed