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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02794623




Registration number
NCT02794623
Ethics application status
Date submitted
6/06/2016
Date registered
9/06/2016
Date last updated
17/08/2016

Titles & IDs
Public title
Tinnitus Suppression for Cochlear Implant Recipients
Scientific title
Evaluation of Tinnitus Suppression for Cochlear Implant Recipients
Secondary ID [1] 0 0
CRC 5583
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tinnitus 0 0
Condition category
Condition code
Ear 0 0 0 0
Other ear disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Tinnitus masking

Experimental: Cochlear Implant Recipients -


Treatment: Devices: Tinnitus masking
Tinnitus masking via CI system

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tinnitus Severity Questionnaire - Tinnitus severity questionnaire using Visual Analog Scale
Timepoint [1] 0 0
Testing over 6 months
Primary outcome [2] 0 0
Word recognition scores in quiet - Monosyllabic word scores in quiet
Timepoint [2] 0 0
Testing over 6 months
Primary outcome [3] 0 0
Speech recognition scores in noise - Sentence recognition scores in noise
Timepoint [3] 0 0
Testing over 6 months
Secondary outcome [1] 0 0
Degree of handicap as a result of tinnitus - Tinnitus Handicap Questionnaire used to capture degree of overall handicap as a result of tinnitus
Timepoint [1] 0 0
Testing over 6 months

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The HEARing CRC - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Hearing Cooperative Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Victoria Eye and Ear Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Cochlear
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02794623
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Robert Cowan, PhD, MBA
Address 0 0
Country 0 0
Phone 0 0
+613 9035 5346
Fax 0 0
Email 0 0
rcowan@hearingcrc.org
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02794623