Cochleural Alternating Acoustic Beam Therapy (CAABT) Versus Masking Intervention for Tinnitus

NCT ID: NCT02774122

Last Updated: 2018-01-23

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-10-31

Brief Summary

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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

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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.

Conditions

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Tinnitus, Subjective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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masking therapy

Masking intervention was a standard monophone tinnitus masking therapy.

Group Type ACTIVE_COMPARATOR

masking therapy

Intervention Type DEVICE

Masking intervention was a standard monophone tinnitus masking therapy.

CAABT

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.

Group Type EXPERIMENTAL

CAABT

Intervention Type DEVICE

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.

Interventions

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CAABT

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

masking therapy

Masking intervention was a standard monophone tinnitus masking therapy.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gong shu-sheng, MD

Role: STUDY_DIRECTOR

Beijing Friendship Hospital

Locations

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Otorhinolaryngology Head and Neck Surgery department

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 22633033 (View on PubMed)

Liu 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.

Reference Type DERIVED
PMID: 38467716 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33013302 (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 DERIVED
PMID: 29655489 (View on PubMed)

Other Identifiers

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961619

Identifier Type: -

Identifier Source: org_study_id

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