Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02794623
Ethics application status
Date submitted
6/06/2016
Date registered
9/06/2016

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
Timepoint [1] 0 0
Testing over 6 months
Primary outcome [2] 0 0
Word recognition scores in quiet
Timepoint [2] 0 0
Testing over 6 months
Primary outcome [3] 0 0
Speech 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
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
Sex
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
NA
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/06/2018
Sample size
Target
Accrual to date
Final
12
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
Government body
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02794623