Tinnitus, Hearing Loss, Cochlear Implant Users Clinical Trial
Official title:
"Cochlear Active Relief From Tinnitus (CART) Sound Therapy" for Tinnitus Relief in Nucleus® Cochlear Implant Users With Tinnitus
| Verified date | February 2019 |
| Source | Cochlear |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 32 |
| Est. completion date | January 24, 2019 |
| Est. primary completion date | January 24, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Department of Otorhinolaryngology, Maastricht University Medical Centre | Maastricht | Limburg |
| Netherlands | Department of Otorhinolaryngology, Head and Neck Surgery | Utrecht |
| Lead Sponsor | Collaborator |
|---|---|
| Cochlear |
Netherlands,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS) score on tinnitus | week 0 | |
| Primary | Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS) score on tinnitus | week 2 | |
| Primary | Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS) score on tinnitus | week 7 | |
| Primary | Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI) | week 0 | ||
| Primary | Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI) | week 2 | ||
| Primary | Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI) | week 7 |