Study on the Effect of Sound Therapy on Chronic Primary Tinnitus
Primary Purpose
Tinnitus
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CAABT
TMT
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
Inclusion Criteria:
- Ages between 18-75 years
- Tinnitus undergone for more than 6 months
- Continuous attack, single tone dominated, annoying tinnitus
- Able to cooperate with auditory function test and psychoacoustic test
- The main tinnitus frequency is from 125Hz to 8000Hz
- Willing to use the equipment daily during the test
- Willing and able to follow up regularly
- Ability to read and write Chinese, able to understand and complete questionnaires
Exclusion Criteria:
- Secondary tinnitus
- Pure tone audiometry shows conduction deafness or mixed deafness
- Tinnitus main frequency threshold >60dB
- Receiving treatment for other tinnitus
- MRI contraindications
- Feeling uncomfortable with the treatment equipment or not being accepted
Sites / Locations
- Beijing Friendship Hospital,Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CAABT
TMT
Arm Description
CAABT(Cochleural Alternating Acoustic Beam Therapy) is 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.
TMT(tinnitus masking therapy) is a traditional tinnitus intervention. The masking sound is mainly white noise, and the intensity just covers tinnitus.
Outcomes
Primary Outcome Measures
Tinnitus Handicap Inventory ( THI)
Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Tinnitus Handicap Inventory scale.
Efficacy evaluation criteria: (1) cure: THI score was reduced to less than 16 points;(2) significant effect: THI score decreased by more than 17 points;(3) invalid: THI score value decreased < 17 points or even increased.Efficiency is the sum of cure and effect.
Resting-state function magnetic resonance imaging(RS-fMRI) Regional homogeneity(ReHo) value
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ReHo value
Resting-state function magnetic resonance imaging(RS-fMRI) low-frequency wave amplitude (ALFF)
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ALFF
Visual Analogue Scale(VAS)
Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Visual Analogue Scale(VAS).
The number 0 to 10 indicates the severity of symptoms, "0" means no symptoms, and "10" means the most severe
Secondary Outcome Measures
Full Information
NCT ID
NCT03764826
First Posted
November 30, 2018
Last Updated
December 8, 2018
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03764826
Brief Title
Study on the Effect of Sound Therapy on Chronic Primary Tinnitus
Official Title
Study on the Effect of Sound Therapy on Chronic Primary Tinnitus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
June 8, 2019 (Anticipated)
Study Completion Date
December 8, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is to compare the effect of Cochleural Alternating Acoustic Beam Therapy(CAABT) and tinnitus masking therapy(TMT) on chronic primary tinnitus.Half of participants will receive CAABT, while the other half will receive TMT.
Detailed Description
The patients with tinnitus will be collected with medical history, ear examination ,auditory function test and questionnaire survey.100 cases of chronic primary tinnitus will be selected as the research object.This study will be developed in the form of a blind randomized clinical trial.The study subjects will be divided into 2 groups by randomized method, with 50 cases in each group. Psychological acoustic test, Resting-state function magnetic resonance imaging(RS-fMRI) will be conducted.For 6 months, the patients will be treated with Cochleural Alternating Acoustic Beam Therapy(CAABT)and tinnitus masking therapy(TMT) respectively, followed by questionnaire survey, psychological acoustics test and RS-fMRI. The THI,VAS score, RS-fMRI ReHo value and low-frequency wave amplitude (ALFF) before and after the treatment will be compared. For those cases with poor results, the exchanged treatment will be performed for 6 months, followed by questionnaire survey, psychoacoustic test, RS-fMRI, and comparison of THI, VAS score, ReHo value and ALFF before and after treatment.All cases will be followed up for 1 year, and questionnaire survey will be conducted again.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAABT
Arm Type
Experimental
Arm Description
CAABT(Cochleural Alternating Acoustic Beam Therapy) is 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.
Arm Title
TMT
Arm Type
Active Comparator
Arm Description
TMT(tinnitus masking therapy) is a traditional tinnitus intervention. The masking sound is mainly white noise, and the intensity just covers tinnitus.
Intervention Type
Device
Intervention Name(s)
CAABT
Intervention Description
The sound generators with CAABT will be used 15 min each session, three times a day
Intervention Type
Device
Intervention Name(s)
TMT
Intervention Description
The sound generators with TMT will be used 15 min each session, three times a day
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory ( THI)
Description
Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Tinnitus Handicap Inventory scale.
Efficacy evaluation criteria: (1) cure: THI score was reduced to less than 16 points;(2) significant effect: THI score decreased by more than 17 points;(3) invalid: THI score value decreased < 17 points or even increased.Efficiency is the sum of cure and effect.
Time Frame
baseline, 2 months, 4 months, 6 months
Title
Resting-state function magnetic resonance imaging(RS-fMRI) Regional homogeneity(ReHo) value
Description
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ReHo value
Time Frame
baseline, 6 months
Title
Resting-state function magnetic resonance imaging(RS-fMRI) low-frequency wave amplitude (ALFF)
Description
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ALFF
Time Frame
baseline, 6 months
Title
Visual Analogue Scale(VAS)
Description
Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Visual Analogue Scale(VAS).
The number 0 to 10 indicates the severity of symptoms, "0" means no symptoms, and "10" means the most severe
Time Frame
baseline, 2 months, 4 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages between 18-75 years
Tinnitus undergone for more than 6 months
Continuous attack, single tone dominated, annoying tinnitus
Able to cooperate with auditory function test and psychoacoustic test
The main tinnitus frequency is from 125Hz to 8000Hz
Willing to use the equipment daily during the test
Willing and able to follow up regularly
Ability to read and write Chinese, able to understand and complete questionnaires
Exclusion Criteria:
Secondary tinnitus
Pure tone audiometry shows conduction deafness or mixed deafness
Tinnitus main frequency threshold >60dB
Receiving treatment for other tinnitus
MRI contraindications
Feeling uncomfortable with the treatment equipment or not being accepted
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Sheng Gong, MD
Phone
13911068366
Email
50228354@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Sheng Gong, MD
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Friendship Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Sheng Gong, MD
First Name & Middle Initial & Last Name & Degree
Zhen-Chang Wang, MD
Phone
010-63138217
Email
cjr.wzhch@vip.163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available within 6 months of study completion
IPD Sharing Time Frame
Data access requests will be reviewed by an external Independent Review Panel.
IPD Sharing Access Criteria
Data access requests will be reviewed by an external Independent Review Panel
Citations:
PubMed Identifier
25274374
Citation
Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus executive summary. Otolaryngol Head Neck Surg. 2014 Oct;151(4):533-41. doi: 10.1177/0194599814547475.
Results Reference
result
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
result
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Study on the Effect of Sound Therapy on Chronic Primary Tinnitus
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