NCT02966366

Brief Summary

Recent studies have reported successful reduction of tinnitus after cochlear implantation (CI) in most CI users, but the mechanisms of reduction and the amount of improvement is not fully understood. Especially, the relative role of peripheral and central auditory pathways is not clearly known. This study assessed the effect of CI electrical stimulation on tinnitus in subjects with unilateral tinnitus related to a single-sided deafness (SSD), and relative contributions of peripheral and central auditory pathways in tinnitus reduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

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

Study Start

First participant enrolled

August 27, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2017

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

3.5 years

First QC Date

November 9, 2016

Last Update Submit

August 21, 2018

Conditions

Single Sided DeafnessTinnitusCochlear Implant

Outcome Measures

Primary Outcomes (4)

  • Change for Visual Analog Scale (VAS) on Intensity and annoyance between pre and post implantation

    Change from pre-implantation Visual Analog Scale (VAS) scores on intensity and annoyance at 1 month after white noise stimulation, 1, 3, 6 and 12 months after conventional stimulation

  • change for THI Tinnitus Handicap Inventory scale between pre and post implantation

    Change from pre-implantation scores on Tinnitus Handicap Inventory Scale (THI scale) at 1 month after white noise stimulation, 1, 3, 6 and 12 months after conventional stimulation

  • Change for TRQ Tinnitus Reaction Questionnaire between pre and post implantation

    Change from pre-implantation scores on Tinnitus Reaction Questionnaire (TRQ) at 1 month after white noise stimulation, 1, 3, 6 and 12 months after conventional stimulation

  • Change for STSS Subjective Tinnitus Severity Scale between pre and post implantation

    Change from pre-implantation scores on Subjective Tinnitus Severity Scale (STSS) at 1 month after white noise stimulation, 1, 3, 6 and 12 months after conventional stimulation

Secondary Outcomes (2)

  • Speech in noise intelligibility

    Before cochlear implantation, 6 and 12 after conventional stimulation

  • Speech in quiet intelligibility with cochlear implant only

    6 and 12 after conventional stimulation

Study Arms (1)

Cochlear implantation

EXPERIMENTAL

Evaluation of tinnitus before and after cochlear implantation

Device: Cochlear implant

Interventions

Cochlear implantDEVICE
Cochlear implantation

Eligibility Criteria

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

You may qualify if:

  • Age over 18
  • Profound to total single sided deafness with associated tinnitus
  • Normal or near-normal hearing on contralateral ear
  • Tinnitus evaluated by THI ≥ 58 and VAS on annoyance ≥8
  • Failure of usual tinnitus treatments
  • Duration of tinnitus between 1 and 15 years
  • Normal vestibular function of contralateral ear
  • Native of fluent French speaker

You may not qualify if:

  • No Social security affiliation
  • Retrocochlear pathology (vestibular schwannoma, severe central auditory processing disorder)
  • Cochlear ossification
  • Middle ear pathology
  • Tinnitus not related to deafness
  • Depression with BDI (Beck Depression Inventory) \> 16 or unfavorable advice from psychologist/ psychiatrist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHRU Lille Hôpital Roger Salengro

Lille, France

Location

CHU Lyon Hôpital Edouard Herriot

Lyon, France

Location

Hôpital la Pitié Salpêtrièr

Paris, France

Location

Hôpital Rothschild

Paris, France

Location

CHU Rennes Pontchaillou

Rennes, France

Location

CHU Tours Bretonneau

Tours, France

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neural ProsthesesImplantable NeurostimulatorsElectrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and ImplantsHearing AidsSensory Aids

Study Officials

  • Dan Gnansia, Dr

    Oticon Medical

    STUDY DIRECTOR

  • Bruno Frachet, Pr

    Hôpital Rothschild

    PRINCIPAL INVESTIGATOR

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

November 9, 2016

First Posted

November 17, 2016

Study Start

August 27, 2013

Primary Completion

March 7, 2017

Study Completion

March 7, 2017

Last Updated

August 22, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)