Tinnitus Suppression for Cochlear Implant Recipients
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|ClinicalTrials.gov Identifier: NCT02794623|
Recruitment Status : Unknown
Verified May 2016 by The Hearing Cooperative Research Centre.
Recruitment status was: Recruiting
First Posted : June 9, 2016
Last Update Posted : August 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Device: Tinnitus masking||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Tinnitus Suppression for Cochlear Implant Recipients|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
|Experimental: Cochlear Implant Recipients||
Device: Tinnitus masking
Tinnitus masking via CI system
- Tinnitus Severity Questionnaire [ Time Frame: Testing over 6 months ]Tinnitus severity questionnaire using Visual Analog Scale
- Word recognition scores in quiet [ Time Frame: Testing over 6 months ]Monosyllabic word scores in quiet
- Speech recognition scores in noise [ Time Frame: Testing over 6 months ]Sentence recognition scores in noise
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794623
|Contact: Robert Cowan, PhD, MBA||+613 9035 email@example.com|
|Contact: Mehrnaz Shoushtarian, PhD||+61 3 8344 firstname.lastname@example.org|
|The HEARing CRC||Recruiting|
|Melbourne, Victoria, Australia, 3002|
|Contact: Robert Cowan, PhD, MBA +61 3 9035 5346 email@example.com|