Tinnitus Suppression for Cochlear Implant Recipients

July 2, 2021 updated by: The Hearing Cooperative Research Centre

Evaluation of Tinnitus Suppression for Cochlear Implant Recipients

Tinnitus is the perception of sound in the absence of an external sound. Prevalence in the general population is 10 to 15%, with tinnitus severely impacting quality of life in 1-2 percent of the population. Tinnitus therapy is based on counselling, cognitive and behavioural therapies in combination with sound therapies which mostly rely on masking.

For cochlear implant candidates, the ability to use hearing aids and maskers is limited by the degree of their hearing loss. Reports of tinnitus prevalence in this group range from 67 to 100% with a mean of 80%.

In cochlear implant (CI) recipients, tinnitus suppression primarily occurs during active use of the cochlear implant system. In some CI recipients residual inhibition of tinnitus occurs when the implant is switched off. While the benefits of CI implantation on tinnitus are well documented, there is a group of recipients where tinnitus remains a concern in the implanted ear post-operatively.

The primary aim of this study is to investigate the benefits of using tinnitus masking via a CI sound processor that optimises tinnitus suppression with minimal annoyance to the user. Furthermore a questionnaire will be employed to capture the prevalence, degree and nature of tinnitus in recipients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • The HEARing CRC

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years of age or older
  2. Freedom or CI500 series implant
  3. At least 3 months experience with the cochlear implant
  4. Native speaker in the language used to assess speech perception performance
  5. Willingness to participate in and to comply with all requirements of the protocol
  6. Self-reported tinnitus in the implanted ear
  7. Reside local to investigational site

Exclusion Criteria:

  1. Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and test including MRI
  2. Additional handicaps that would prevent participations in evaluations
  3. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cochlear Implant Recipients
Device: Tinnitus masking
Tinnitus masking via CI system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Severity Questionnaire
Time Frame: Testing over 6 months
Tinnitus severity questionnaire using Visual Analog Scale
Testing over 6 months
Word recognition scores in quiet
Time Frame: Testing over 6 months
Monosyllabic word scores in quiet
Testing over 6 months
Speech recognition scores in noise
Time Frame: Testing over 6 months
Sentence recognition scores in noise
Testing over 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of handicap as a result of tinnitus
Time Frame: Testing over 6 months
Tinnitus Handicap Questionnaire used to capture degree of overall handicap as a result of tinnitus
Testing over 6 months

Collaborators and Investigators

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

Sponsor

The Hearing Cooperative Research Centre

Collaborators

Royal Victoria Eye and Ear Hospital
Cochlear

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)

October 18, 2014

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

June 8, 2018

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (ESTIMATE)

June 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC 5583

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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