Cochleural Alternating Acoustic Beam Therapy Versus Masking Intervention for Tinnitus: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Tinnitus Subjective Measures at 12 weeks: tinnitus loudness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
masking therapy
Masking intervention was a standard monophone tinnitus masking therapy.
Intervention: masking therapy (Device)
CAABT
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.
Intervention: CAABT (Device)
Outcomes
Primary Outcomes
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: tinnitus loudness
Time Frame: baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: minimize masking level
Time Frame: baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Visual Analog Scale
Time Frame: baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: pure tone audiometry
Time Frame: baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Chinese version of Tinnitus Handicap Inventory scale
Time Frame: baseline and 12 weeks
Secondary Outcomes
- Change from Baseline in Tinnitus Objective Measure at 12 weeks: functional magnetic resonance imaging (fMRI)(baseline and 12 weeks)
Investigators
Shu-sheng Gong
director
Beijing Friendship Hospital