Sound Therapy for Tinnitus Relief in Cochlear Implant Users

Not Applicable

Terminated

• Conditions: Tinnitus, Hearing Loss, Cochlear Implant Users
• Interventions: Device: CART sound therapy

• Registration Number: NCT03026829
• Lead Sponsor: Cochlear

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-16
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-20
• Study Start: 2017-10-03
• Primary Completion: 2019-01-24
• Study Completion: 2019-01-24
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CART sound therapy	CART sound therapy	-

Primary Outcome Measures

Name	Time	Method
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)	week 7	Visual Analogue Scale (VAS) score on tinnitus
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)	week 7

Trial Locations

Locations (2)

Department of Otorhinolaryngology, Maastricht University Medical Centre; 🇳🇱 Maastricht, Limburg, Netherlands

Department of Otorhinolaryngology, Head and Neck Surgery; 🇳🇱 Utrecht, Netherlands