Cochleural Alternating Acoustic Beam Therapy (CAABT) Versus Masking Intervention for Tinnitus
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 8, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedJanuary 23, 2018
January 1, 2018
2.3 years
May 8, 2016
January 20, 2018
Conditions
Outcome Measures
Primary Outcomes (5)
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
Secondary Outcomes (1)
Change from Baseline in Tinnitus Objective Measure at 12 weeks: functional magnetic resonance imaging (fMRI)
baseline and 12 weeks
Study Arms (2)
masking therapy
ACTIVE COMPARATORMasking intervention was a standard monophone tinnitus masking therapy.
CAABT
EXPERIMENTALCAABT 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.
Interventions
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.
Masking intervention was a standard monophone tinnitus masking therapy.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Otorhinolaryngology Head and Neck Surgery department
Beijing, Beijing Municipality, 100031, China
Related Publications (4)
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.
PMID: 22633033RESULTLiu 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.
PMID: 38467716DERIVEDWei 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.
PMID: 33013302DERIVEDLiu 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.
PMID: 29655489DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gong shu-sheng, MD
Beijing Friendship Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director
Study Record Dates
First Submitted
May 8, 2016
First Posted
May 17, 2016
Study Start
April 1, 2016
Primary Completion
August 1, 2018
Study Completion
October 1, 2018
Last Updated
January 23, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be made available within 6 months of study completion
- Access Criteria
- Data access requests will be reviewed by an external Independent Review Panel.
individual participant data(IPD) for all subjective and objective outcome measures will be made available within 6 months of study completion