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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02794623
Registration number
NCT02794623
Ethics application status
Date submitted
6/06/2016
Date registered
9/06/2016
Date last updated
6/07/2021
Titles & IDs
Public title
Tinnitus Suppression for Cochlear Implant Recipients
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Scientific title
Evaluation of Tinnitus Suppression for Cochlear Implant Recipients
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Secondary ID [1]
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CRC 5583
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tinnitus
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Condition category
Condition code
Ear
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Other ear disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Tinnitus masking
Experimental: Cochlear Implant Recipients -
Treatment: Devices: Tinnitus masking
Tinnitus masking via CI system
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Tinnitus Severity Questionnaire
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Assessment method [1]
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Tinnitus severity questionnaire using Visual Analog Scale
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Timepoint [1]
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Testing over 6 months
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Primary outcome [2]
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Word recognition scores in quiet
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Assessment method [2]
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Monosyllabic word scores in quiet
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Timepoint [2]
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Testing over 6 months
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Primary outcome [3]
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Speech recognition scores in noise
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Assessment method [3]
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Sentence recognition scores in noise
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Timepoint [3]
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Testing over 6 months
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Secondary outcome [1]
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Degree of handicap as a result of tinnitus
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Assessment method [1]
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Tinnitus Handicap Questionnaire used to capture degree of overall handicap as a result of tinnitus
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Timepoint [1]
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Testing over 6 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/10/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/06/2018
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Sample size
Target
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Accrual to date
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Final
12
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The HEARing CRC - Melbourne
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Recruitment postcode(s) [1]
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3002 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Hearing Cooperative Research Centre
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Royal Victoria Eye and Ear Hospital
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Cochlear
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02794623
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02794623
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