Cochleural Alternating Acoustic Beam Therapy (CAABT) Versus Masking Intervention for Tinnitus
Primary Purpose
Tinnitus, Subjective
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CAABT
masking therapy
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus, Subjective
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
Sites / Locations
- Otorhinolaryngology Head and Neck Surgery department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
masking therapy
CAABT
Arm Description
Masking intervention was a standard monophone tinnitus masking therapy.
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.
Outcomes
Primary Outcome Measures
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: pure tone audiometry
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: tinnitus loudness
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: minimize masking level
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Chinese version of Tinnitus Handicap Inventory scale
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Visual Analog Scale
Secondary Outcome Measures
Change from Baseline in Tinnitus Objective Measure at 12 weeks: functional magnetic resonance imaging (fMRI)
Full Information
NCT ID
NCT02774122
First Posted
May 8, 2016
Last Updated
January 20, 2018
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02774122
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
masking therapy
Arm Type
Active Comparator
Arm Description
Masking intervention was a standard monophone tinnitus masking therapy.
Arm Title
CAABT
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
CAABT
Intervention Description
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 Type
Device
Intervention Name(s)
masking therapy
Intervention Description
Masking intervention was a standard monophone tinnitus masking therapy.
Primary Outcome Measure Information:
Title
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: pure tone audiometry
Time Frame
baseline and 12 weeks
Title
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: tinnitus loudness
Time Frame
baseline and 12 weeks
Title
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: minimize masking level
Time Frame
baseline and 12 weeks
Title
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Chinese version of Tinnitus Handicap Inventory scale
Time Frame
baseline and 12 weeks
Title
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Visual Analog Scale
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Tinnitus Objective Measure at 12 weeks: functional magnetic resonance imaging (fMRI)
Time Frame
baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gong shu-sheng, MD
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Otorhinolaryngology Head and Neck Surgery department
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100031
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
individual participant data(IPD) for all subjective and objective outcome measures will be made available within 6 months of study completion
IPD Sharing Time Frame
Data will be made available within 6 months of study completion
IPD Sharing Access Criteria
Data access requests will be reviewed by an external Independent Review Panel.
Citations:
PubMed Identifier
22633033
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.
Results Reference
result
PubMed Identifier
33013302
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.
Results Reference
derived
PubMed Identifier
29655489
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.
Results Reference
derived
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Cochleural Alternating Acoustic Beam Therapy (CAABT) Versus Masking Intervention for Tinnitus
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