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This study is to compare the effectiveness of CAABT and masking therapy in the management of subjective tinnitus in adults.Half of participants will receive CAABT, while the other half will receive masking therapy.
Masking intervention was a standard monophone tinnitus masking therapy. It was usually a narrow-band noise matched with tinnitus frequency (Tf).
CAABT was 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| masking therapy | Active Comparator | Masking intervention was a standard monophone tinnitus masking therapy. |
|
| CAABT | Experimental | CAABT was 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAABT | Device | CAABT was 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Tinnitus Subjective Measures at 12 weeks: pure tone audiometry | baseline and 12 weeks | |
| Change from Baseline in Tinnitus Subjective Measures at 12 weeks: tinnitus loudness | baseline and 12 weeks | |
| Change from Baseline in Tinnitus Subjective Measures at 12 weeks: minimize masking level | baseline and 12 weeks | |
| Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Chinese version of Tinnitus Handicap Inventory scale | baseline and 12 weeks | |
| Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Visual Analog Scale | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Tinnitus Objective Measure at 12 weeks: functional magnetic resonance imaging (fMRI) | baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gong shu-sheng, MD | Beijing Friendship Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otorhinolaryngology Head and Neck Surgery department | Beijing | Beijing Municipality | 100031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22633033 | Result | Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, Anteunis LJ, van Breukelen GJ, Vlaeyen JW. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9830):1951-9. doi: 10.1016/S0140-6736(12)60469-3. | |
| 38467716 | Derived |
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individual participant data(IPD) for all subjective and objective outcome measures will be made available within 6 months of study completion
Data will be made available within 6 months of study completion
Data access requests will be reviewed by an external Independent Review Panel.
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| masking therapy | Device | Masking intervention was a standard monophone tinnitus masking therapy. |
|
| Liu C, Zhang J, Qi Z, Yue W, Yuan Y, Jiang T, Zhang S, Zhang S. Therapy effect of cochleural alternating acoustic beam therapy versus traditional sound therapy for managing chronic idiopathic tinnitus patients. Sci Rep. 2024 Mar 11;14(1):5900. doi: 10.1038/s41598-024-55866-0. |
| 33013302 | Derived | Wei X, Lv H, Wang Z, Liu C, Ren P, Zhang P, Chen Q, Liu Y, Zhao P, Gong S, Yang Z, Wang Z. Neuroanatomical Alterations in Patients With Tinnitus Before and After Sound Therapy: A Voxel-Based Morphometry Study. Front Neurosci. 2020 Sep 8;14:911. doi: 10.3389/fnins.2020.00911. eCollection 2020. |
| 29655489 | Derived | Liu C, Lv H, Jiang T, Xie J, He L, Wang G, Liu J, Wang Z, Gong S. The Cochleural Alternating Acoustic Beam Therapy (CAABT): A pre-clinical trial. Am J Otolaryngol. 2018 Jul-Aug;39(4):401-409. doi: 10.1016/j.amjoto.2018.04.002. Epub 2018 Apr 3. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |