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Sound Therapy for Tinnitus Relief in Cochlear Implant Users

Primary Purpose

Tinnitus, Hearing Loss, Cochlear Implant Users

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
CART sound therapy
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Hearing Loss, Cochlear Implant Users focused on measuring Sound therapy, Tinnitus relief

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CART sound therapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 16, 2017
Last Updated
February 14, 2019
Sponsor
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT03026829
Brief Title
Sound Therapy for Tinnitus Relief in Cochlear Implant Users
Official Title
"Cochlear Active Relief From Tinnitus (CART) Sound Therapy" for Tinnitus Relief in Nucleus® Cochlear Implant Users With Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Number of subjects could not be achieved due to slow recruitment
Study Start Date
October 3, 2017 (Actual)
Primary Completion Date
January 24, 2019 (Actual)
Study Completion Date
January 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Hearing Loss, Cochlear Implant Users
Keywords
Sound therapy, Tinnitus relief

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CART sound therapy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CART sound therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Description
Visual Analogue Scale (VAS) score on tinnitus
Time Frame
week 0
Title
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Description
Visual Analogue Scale (VAS) score on tinnitus
Time Frame
week 2
Title
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Description
Visual Analogue Scale (VAS) score on tinnitus
Time Frame
week 7
Title
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
Time Frame
week 0
Title
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
Time Frame
week 2
Title
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
Time Frame
week 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Volckaerts, PhD
Organizational Affiliation
Cochlear
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Otorhinolaryngology, Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
Country
Netherlands
Facility Name
Department of Otorhinolaryngology, Head and Neck Surgery
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
26001407
Citation
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.
Results Reference
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Sound Therapy for Tinnitus Relief in Cochlear Implant Users

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