An interventional study of CAABT and TMT in Tinnitus, sponsored by Beijing Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-12-11.
Sponsored by Beijing Friendship Hospital · Not applicable, Interventional, and Treatment
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.
412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 339 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.
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Exclusion Criteria:
CAABT(Cochleural Alternating Acoustic Beam Therapy) is 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.
Device: CAABT
TMT(tinnitus masking therapy) is a traditional tinnitus intervention. The masking sound is mainly white noise, and the intensity just covers tinnitus.
Device: TMT
The sound generators with CAABT will be used 15 min each session, three times a day
The sound generators with TMT will be used 15 min each session, three times a day
Tinnitus 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
Plan to share: Yes — Data will be made available within 6 months of study completion
Supporting information: Study protocol
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Beijing Friendship Hospital