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

Cochlear2 sites in 1 country32 target enrollmentOctober 3, 2017

ConditionsTinnitus, Hearing Loss, Cochlear Implant Users

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tinnitus, Hearing Loss, Cochlear Implant Users
Sponsor: Cochlear
Enrollment: 32
Locations: 2
Primary Endpoint: Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 3, 2017

End Date

January 24, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cochlear

Responsible Party

Sponsor

Eligibility Criteria

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