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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
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 8, 2016
Last Updated
January 20, 2018
Sponsor
Beijing Friendship Hospital
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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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