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

January 20, 2018 updated by: Shu-sheng Gong, Beijing Friendship Hospital

Cochleural Alternating Acoustic Beam Therapy Versus Masking Intervention for Tinnitus: A Randomised Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100031
        • Otorhinolaryngology Head and Neck Surgery department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: masking therapy
Masking intervention was a standard monophone tinnitus masking therapy.
Device: masking therapy
Masking intervention was a standard monophone tinnitus masking therapy.
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: pure tone audiometry
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: tinnitus loudness
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: minimize masking level
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Chinese version of Tinnitus Handicap Inventory scale
Time Frame: baseline and 12 weeks
baseline and 12 weeks
Change from Baseline in Tinnitus Subjective Measures at 12 weeks: the Visual Analog Scale
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Tinnitus Objective Measure at 12 weeks: functional magnetic resonance imaging (fMRI)
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Study Director: Gong shu-sheng, MD, Beijing Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

May 8, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 17, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 20, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 961619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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