Sound Therapy for Tinnitus Relief in Cochlear Implant Users

February 14, 2019 updated by: Cochlear

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands
        • Department of Otorhinolaryngology, Head and Neck Surgery
    • Limburg
      • Maastricht, Limburg, Netherlands
        • Department of Otorhinolaryngology, Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CART sound therapy
Device: CART sound therapy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Time Frame: week 0
Visual Analogue Scale (VAS) score on tinnitus
week 0
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Time Frame: week 2
Visual Analogue Scale (VAS) score on tinnitus
week 2
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Time Frame: week 7
Visual Analogue Scale (VAS) score on tinnitus
week 7
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
Time Frame: week 0
week 0
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
Time Frame: week 2
week 2
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
Time Frame: week 7
week 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Investigators

  • Study Chair: Bart Volckaerts, PhD, Cochlear

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2017

Primary Completion (Actual)

January 24, 2019

Study Completion (Actual)

January 24, 2019

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEL5684

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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