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Tinnitus Suppression for Cochlear Implant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Royal Victoria Eye and Ear Hospital
Cochlear
Information provided by (Responsible Party):
The Hearing Cooperative Research Centre

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.


Condition or disease Intervention/treatment Phase
Tinnitus Device: Tinnitus masking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cochlear Implant Recipients Device: Tinnitus masking
Tinnitus masking via CI system




Primary Outcome Measures :
  1. Tinnitus Severity Questionnaire [ Time Frame: Testing over 6 months ]
    Tinnitus severity questionnaire using Visual Analog Scale

  2. Word recognition scores in quiet [ Time Frame: Testing over 6 months ]
    Monosyllabic word scores in quiet

  3. Speech recognition scores in noise [ Time Frame: Testing over 6 months ]
    Sentence recognition scores in noise


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Robert Cowan, PhD, MBA +613 9035 5346 rcowan@hearingcrc.org
Contact: Mehrnaz Shoushtarian, PhD +61 3 8344 4982 mshoushtarian@hearingcrc.org

Locations
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Australia, Victoria
The HEARing CRC Recruiting
Melbourne, Victoria, Australia, 3002
Contact: Robert Cowan, PhD, MBA    +61 3 9035 5346    rcowan@hearingcrc.org   
Sponsors and Collaborators
The Hearing Cooperative Research Centre
Royal Victoria Eye and Ear Hospital
Cochlear
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Responsible Party: The Hearing Cooperative Research Centre
ClinicalTrials.gov Identifier: NCT02794623    
Other Study ID Numbers: CRC 5583
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The Hearing Cooperative Research Centre:
cochlear implants
hearing loss
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms