TinnitusNCT02794623
Tinnitus Suppression for Cochlear Implant Recipients
A study testing Tinnitus masking in people with Tinnitus, run by The Hearing Cooperative Research Centre at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Tinnitus masking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Oct 2014to 8 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Freedom or CI500 series implant
- At least 3 months experience with the cochlear implant
- Native speaker in the language used to assess speech perception performance
- Willingness to participate in and to comply with all requirements of the protocol
- Self-reported tinnitus in the implanted ear
- Reside local to investigational site
Who cannot join
- Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and test including MRI
- Additional handicaps that would prevent participations in evaluations
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Tinnitus Suppression for Cochlear Implant Recipients
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%.
Read more
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.
- Conditions
- Tinnitus
- Being tested
- Tinnitus masking
- Keywords
- cochlear implants, hearing loss
- Medical subject headings
- Tinnitus, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinnitus maskingDevice
Tinnitus masking via CI system
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant Recipients | Experimental | Not described Receives: Device: Tinnitus masking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Severity Questionnaire
Tinnitus severity questionnaire using Visual Analog Scale
Measured: Testing over 6 months
Word recognition scores in quiet
Monosyllabic word scores in quiet
Measured: Testing over 6 months
Speech recognition scores in noise
Sentence recognition scores in noise
Measured: Testing over 6 months
Secondary outcomes (1)
Degree of handicap as a result of tinnitus
Tinnitus Handicap Questionnaire used to capture degree of overall handicap as a result of tinnitus
Measured: Testing over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study start18 Oct 2014
- Primary completionMar 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hearing Cooperative Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Victoria Eye and Ear Hospital, Cochlear
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794623
- Sponsor's protocol ID
- CRC 5583
- Status last verified
- Jul 2021
- First submitted
- 6 Jun 2016
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tinnitus Suppression for Cochlear Implant Recipients
- ClinicalTrials.gov ID
- NCT02794623
- Acronym / sponsor ID
- CRC 5583
- Conditions
- Tinnitus
- Keywords
- cochlear implants, hearing loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Hearing Cooperative Research CentreUniversity, hospital or other
- Collaborators
- Royal Victoria Eye and Ear Hospital, Cochlear
- Study start
- 18 Oct 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant Recipients | Experimental | Device: Tinnitus masking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Freedom or CI500 series implant
- At least 3 months experience with the cochlear implant
- Native speaker in the language used to assess speech perception performance
- Willingness to participate in and to comply with all requirements of the protocol
Key exclusion criteria (3 listed)
- Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and test including MRI
- Additional handicaps that would prevent participations in evaluations
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinnitus maskingTinnitus masking via CI system | Device | Cochlear Implant Recipients |
Primary outcome
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
1 secondary outcome
Degree of handicap as a result of tinnitus
Time frame: Testing over 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tinnitus masking in people with Tinnitus, run by The Hearing Cooperative Research Centre at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Severity Questionnaire (time frame: Testing over 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.