NCT03026829

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

October 3, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

January 16, 2017

Last Update Submit

February 14, 2019

Conditions

Tinnitus, Hearing Loss, Cochlear Implant Users

Keywords

Sound therapyTinnitus relief

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (1)

CART sound therapy

EXPERIMENTAL
Device: CART sound therapy

Interventions

CART sound therapyDEVICE

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

CART sound therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Otorhinolaryngology, Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Location

Department of Otorhinolaryngology, Head and Neck Surgery

Utrecht, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 26001407BACKGROUND

MeSH Terms

Conditions

TinnitusHearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bart Volckaerts, PhD

    Cochlear

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 20, 2017

Study Start

October 3, 2017

Primary Completion

January 24, 2019

Study Completion

January 24, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

NL(2)