Clinical trial NCT02774122: Cochleural Alternating Acoustic Beam Therapy (CAABT) Versus Masking Intervention for Tinnitus
Official title: Cochleural Alternating Acoustic Beam Therapy Versus Masking Intervention for Tinnitus: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus, Subjective
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Unilateral tinnitus
* Ages between 18-80 years
* Tinnitus undergone for more than 6 months
* Hearing loss of the tinnitus ear not affect communication
* The main tinnitus frequency is less than 8 KHz
* Primary tinnitus

Exclusion Criteria:

* Secondary tinnitus
* Hyperacusis
* Patients were accepting any therapy about tinnitus
* Those who have serious mental illness
* Patients who can't fit the audiological examination and tinnitus tests
* Most of the hearing loss in the middle and severe hearing loss of the tinnitus ear
* Any MRI contraindications

Primary outcomes:
measure: Change from Baseline in Tinnitus Subjective Measures at 12 weeks: pure tone audiometry
timeFrame: baseline and 12 weeks
measure: Change from Baseline in Tinnitus Subjective Measures at 12 weeks: tinnitus loudness
timeFrame: baseline and 12 weeks
measure: Change from Baseline in Tinnitus Subjective Measures at 12 weeks: minimize masking level
timeFrame: baseline and 12 weeks
measure: Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Chinese version of Tinnitus Handicap Inventory scale
timeFrame: baseline and 12 weeks
measure: Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Visual Analog Scale
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change from Baseline in Tinnitus Objective Measure at 12 weeks: functional magnetic resonance imaging (fMRI)
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Otorhinolaryngology Head and Neck Surgery department
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Gong shu-sheng, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.