Tinnitus, Hearing Loss, Cochlear Implant UsersNCT03026829
Sound Therapy for Tinnitus Relief in Cochlear Implant Users
A study testing CART sound therapy in people with Tinnitus, Hearing Loss, Cochlear Implant Users, run by Cochlear at 2 sites in Netherlands.
Trial summary
The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from Tinnitus (CART) firmware. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Hearing Loss, Cochlear Implant Users
- What is being tested?
- CART sound therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesNetherlands
- Study dates
- 3 Oct 2017to 24 Jan 2019
- 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
- Self-reported tinnitus during standard Cochlear Implant (CI) activation for at least one month
- At least three months use of unilateral or bilateral Nucleus CI(s) driven by a CP900 Sound Processor. For bilateral use the most recently activated CI is used for at least three months
- Native speaker and fluency in the language used in the assessments (i.e. Dutch)
Who cannot join
- Additional handicaps that would prevent participation in evaluations
- History of psychiatric disorders or depression (on investigator's opinion)
- Unrealistic expectations as identified by the clinician on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study
- Pulsatile or diagnosed objective / middle ear tinnitus
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Department of Otorhinolaryngology, Maastricht University Medical Centre
Maastricht, Limburg
Department of Otorhinolaryngology, Head and Neck Surgery
Utrecht
About this study
Official title: "Cochlear Active Relief From Tinnitus (CART) Sound Therapy" for Tinnitus Relief in Nucleus® Cochlear Implant Users With Tinnitus
The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from Tinnitus (CART) firmware.
- Being tested
- CART sound therapy
- Keywords
- Sound therapy, Tinnitus relief
- 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.
CART sound therapyDevice
The study consists of two parts:
Phase 1: laboratory evaluation of CART sound acceptability
Phase 2: take home evaluation of CART sound therapy including baseline without CART
| Study group | Role | What they receive |
|---|---|---|
| CART sound therapy | Experimental | Not described Receives: Device: CART sound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) score on tinnitus
Measured: week 0
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) score on tinnitus
Measured: week 2
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) score on tinnitus
Measured: week 7
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
Measured: week 0
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
Measured: week 2
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
Measured: week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start3 Oct 2017
- Primary completion24 Jan 2019
- Study completion24 Jan 2019
Why it stopped: Number of subjects could not be achieved due to slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, Hearing Loss, Cochlear Implant UsersStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bart Volckaerts, PhD, Study chair, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026829
- Sponsor's protocol ID
- CEL5684
- Status last verified
- Feb 2019
- First submitted
- 16 Jan 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tyler RS, Keiner AJ, Walker K, Deshpande AK, Witt S, Killian M, Ji H, Patrick J, Dillier N, van Dijk P, Lai WK, Hansen MR, Gantz B. A Series of Case Studies of Tinnitus Suppression With Mixed Background Stimuli in a Cochlear Implant. Am J Audiol. 2015 Sep;24(3):398-410. doi: 10.1044/2015_AJA-15-0005.
PubMed 26001407
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Cochlear Active Relief From Tinnitus (CART) Sound Therapy" for Tinnitus Relief in Nucleus® Cochlear Implant Users With Tinnitus
- ClinicalTrials.gov ID
- NCT03026829
- Acronym / sponsor ID
- CEL5684
- Keywords
- Sound therapy, Tinnitus relief
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Number of subjects could not be achieved due to slow recruitment
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 20 Jan 2017 (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.
The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from Tinnitus (CART) firmware.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CART sound therapy | Experimental | Device: CART sound therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Self-reported tinnitus during standard Cochlear Implant (CI) activation for at least one month
- At least three months use of unilateral or bilateral Nucleus CI(s) driven by a CP900 Sound Processor. For bilateral use the most recently activated CI is used for at least three months
- Native speaker and fluency in the language used in the assessments (i.e. Dutch)
Key exclusion criteria (4 listed)
- Additional handicaps that would prevent participation in evaluations
- History of psychiatric disorders or depression (on investigator's opinion)
- Unrealistic expectations as identified by the clinician on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study
- Pulsatile or diagnosed objective / middle ear tinnitus
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 |
|---|---|---|
| CART sound therapyThe study consists of two parts: Phase 1: laboratory evaluation of CART sound acceptability Phase 2: take home evaluation of CART sound therapy including baseline without CART | Device | CART sound therapy |
Primary outcome
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Time frame: week 0
Visual Analogue Scale (VAS) score on tinnitus
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Time frame: week 2
Visual Analogue Scale (VAS) score on tinnitus
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Time frame: week 7
Visual Analogue Scale (VAS) score on tinnitus
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
Time frame: week 0
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
Time frame: week 2
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
Time frame: week 7
Results and safety
The study was stopped early (reason given: Number of subjects could not be achieved due to slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Background: PubMed 26001407Tyler RS, Keiner AJ, Walker K, Deshpande AK, Witt S, Killian M, Ji H, Patrick J, Dillier N, van Dijk P, Lai WK, Hansen MR, Gantz B. A Series of Case Studies of Tinnitus Suppression With Mixed Background Stimuli in a Cochlear Implant. Am J Audiol. 2015 Sep;24(3):398-410. doi: 10.1044/2015_AJA-15-0005.
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.
Bart Volckaerts, PhD study chair
Cochlear
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CART sound therapy in people with Tinnitus, Hearing Loss, Cochlear Implant Users, run by Cochlear at 2 sites in Netherlands.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 was stopped early (reason given: Number of subjects could not be achieved due to slow recruitment). Results are not available in the source record.
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?
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS) (time frame: week 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03026829, which also lists 1 linked publication.
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 15 Feb 2019.