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Number of subjects could not be achieved due to slow recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CART sound therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CART sound therapy | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS) score on tinnitus | week 0 |
| Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS) score on tinnitus | week 2 |
| Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS) score on tinnitus | week 7 |
| Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI) | week 0 | |
| Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI) | week 2 | |
| Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI) | week 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bart Volckaerts, PhD | Cochlear | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology, Maastricht University Medical Centre | Maastricht | Limburg | Netherlands | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26001407 | Background | 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. |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Department of Otorhinolaryngology, Head and Neck Surgery |
| Utrecht |
| Netherlands |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |