Sound Therapy for Tinnitus Relief in Cochlear Implant Users

Study Overview
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Brief Summary
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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.

Official Title
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Cochlear Active Relief From Tinnitus (CART) Sound Therapy for Tinnitus Relief in Nucleus® Cochlear Implant Users With Tinnitus

Conditions
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Tinnitus, Hearing Loss, Cochlear Implant Users

Intervention / Treatment
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* Device: CART sound therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CART sound therapy<br> | Device: CART sound therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sound therapy, Tinnitus relief