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Study on the Effect of Sound Therapy on Chronic Primary Tinnitus

NCT ID: NCT03764826

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-12-08

Brief Summary

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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

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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.

Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CAABT

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.

Group Type EXPERIMENTAL

CAABT

Intervention Type DEVICE

The sound generators with CAABT will be used 15 min each session, three times a day

TMT

TMT(tinnitus masking therapy) is a traditional tinnitus intervention. The masking sound is mainly white noise, and the intensity just covers tinnitus.

Group Type ACTIVE_COMPARATOR

TMT

Intervention Type DEVICE

The sound generators with TMT will be used 15 min each session, three times a day

Interventions

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CAABT

The sound generators with CAABT will be used 15 min each session, three times a day

Intervention Type DEVICE

TMT

The sound generators with TMT will be used 15 min each session, three times a day

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shu-sheng Gong

director of Department of Otorhinolaryngology Head and Neck Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shu-Sheng Gong, MD

Role: STUDY_DIRECTOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shu-Sheng Gong, MD

Role: CONTACT

Phone: 13911068366

Email: [email protected]

Facility Contacts

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Shu-Sheng Gong, MD

Role: primary

Zhen-Chang Wang, MD

Role: backup

References

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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.

Reference Type RESULT
PMID: 25274374 (View on PubMed)

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.

Reference Type RESULT
PMID: 29655489 (View on PubMed)

Other Identifiers

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2018-P2-182-01

Identifier Type: -

Identifier Source: org_study_id