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Tinnitus Suppression for Cochlear Implant Recipients

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Tinnitus masking
Sponsored by
The Hearing Cooperative Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring cochlear implants, hearing loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The HEARing CRC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cochlear Implant Recipients

Arm Description

Outcomes

Primary Outcome Measures

Tinnitus Severity Questionnaire
Tinnitus severity questionnaire using Visual Analog Scale
Word recognition scores in quiet
Monosyllabic word scores in quiet
Speech recognition scores in noise
Sentence recognition scores in noise

Secondary Outcome Measures

Degree of handicap as a result of tinnitus
Tinnitus Handicap Questionnaire used to capture degree of overall handicap as a result of tinnitus

Full Information

First Posted
June 6, 2016
Last Updated
July 2, 2021
Sponsor
The Hearing Cooperative Research Centre
Collaborators
Royal Victoria Eye and Ear Hospital, Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT02794623
Brief Title
Tinnitus Suppression for Cochlear Implant Recipients
Official Title
Evaluation of Tinnitus Suppression for Cochlear Implant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
June 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hearing Cooperative Research Centre
Collaborators
Royal Victoria Eye and Ear Hospital, Cochlear

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
cochlear implants, hearing loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cochlear Implant Recipients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Tinnitus masking
Intervention Description
Tinnitus masking via CI system
Primary Outcome Measure Information:
Title
Tinnitus Severity Questionnaire
Description
Tinnitus severity questionnaire using Visual Analog Scale
Time Frame
Testing over 6 months
Title
Word recognition scores in quiet
Description
Monosyllabic word scores in quiet
Time Frame
Testing over 6 months
Title
Speech recognition scores in noise
Description
Sentence recognition scores in noise
Time Frame
Testing over 6 months
Secondary Outcome Measure Information:
Title
Degree of handicap as a result of tinnitus
Description
Tinnitus Handicap Questionnaire used to capture degree of overall handicap as a result of tinnitus
Time Frame
Testing over 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Freedom or CI500 series implant At least 3 months experience with the cochlear implant Native speaker in the language used to assess speech perception performance Willingness to participate in and to comply with all requirements of the protocol Self-reported tinnitus in the implanted ear Reside local to investigational site Exclusion Criteria: Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and test including MRI Additional handicaps that would prevent participations in evaluations Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study
Facility Information:
Facility Name
The HEARing CRC
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tinnitus Suppression for Cochlear Implant Recipients

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