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Tinnitus Treatment With Cochlear Implant in Single Sided Deafness

Primary Purpose

Single Sided Deafness, Tinnitus, Cochlear Implant

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cochlear implant
Sponsored by
Oticon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Single Sided Deafness

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • CHRU Lille Hôpital Roger Salengro
  • CHU Lyon Hôpital Edouard Herriot
  • Hôpital la Pitié Salpêtrièr
  • Hôpital Rothschild
  • CHU Rennes Pontchaillou
  • CHU Tours Bretonneau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cochlear implantation

Arm Description

Evaluation of tinnitus before and after cochlear implantation

Outcomes

Primary Outcome Measures

Change for Visual Analog Scale (VAS) on Intensity and annoyance between pre and post implantation
change for THI Tinnitus Handicap Inventory scale between pre and post implantation
Change for TRQ Tinnitus Reaction Questionnaire between pre and post implantation
Change for STSS Subjective Tinnitus Severity Scale between pre and post implantation

Secondary Outcome Measures

Speech in noise intelligibility
Comparison of speech intelligibility in noise with and without the speech processor, when measured in free field, with the normal hearing ear unplugged. Performance (% of words correctly repeated) is measured: With two level of noise (Speech to Noise Ratio of -3dB and +5 dB) In three different spatial configurations: (S0N0: signal and noise coming from the front; S0NIC: Signal coming from the front and noise coming from the implanted side; SICN0: Signal coming from the implanted side and noise coming from the front.
Speech in quiet intelligibility with cochlear implant only
Speech intelligibility for speech in quiet with the cochlear implant only (speech signals presented through direct connection).

Full Information

First Posted
November 9, 2016
Last Updated
August 21, 2018
Sponsor
Oticon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02966366
Brief Title
Tinnitus Treatment With Cochlear Implant in Single Sided Deafness
Official Title
Tinnitus Treatment With Cochlear Implant in Single Sided Deafness
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 27, 2013 (Actual)
Primary Completion Date
March 7, 2017 (Actual)
Study Completion Date
March 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Introduction: Continuous surgical, technological and audiological advances are responsible for the ever improvement of outcomes obtained through cochlear implants (CI) over the last decades. These positive observations have progressively led to the cautious extension of CI indications including patients with single-sided deafness (SSD). SSD patients are characterized by the loss of functional hearing in one ear, causing an impairment of binaural hearing abilities, with important difficulties for sound localization and speech in noise comprehension. These patients also often present invalidating tinnitus in the deaf ear, worsening both their psychological and audiological conditions. Recent studies have reported successful reduction of tinnitus intensity after cochlear implantation. However, most studies included a very limited number of participants and tinnitus evaluation tools. The impact of CI speech perception abilities in SSD is still under debate. Objective: This study aims to assess the effect of CI electrical stimulation on tinnitus, speech-in-noise and speech-in-quiet abilities in a group of 30 SSD patients. Methods: After cochlear implantation, patients are stimulated using continuous white noise stimulation in the first month period and thereafter using a conventional stimulation. This was done to investigate the effects of non-meaningful, and therefore only peripheral, stimulation. Outcomes were monitored at 1, 3, 6 and 12 months of CI use. Tinnitus loudness and annoyance were measured with a Visual Analog Scale and tinnitus distress and quality of life were evaluated with tinnitus questionnaires (THI, TRQ and STSS). Speech in noise comprehension was assessed in three different spatial listening configurations and speech in quiet was evaluated through direct connection with the speech processor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single Sided Deafness, Tinnitus, Cochlear Implant

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cochlear implantation
Arm Type
Experimental
Arm Description
Evaluation of tinnitus before and after cochlear implantation
Intervention Type
Device
Intervention Name(s)
Cochlear implant
Primary Outcome Measure Information:
Title
Change for Visual Analog Scale (VAS) on Intensity and annoyance between pre and post implantation
Time Frame
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
Title
change for THI Tinnitus Handicap Inventory scale between pre and post implantation
Time Frame
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
Title
Change for TRQ Tinnitus Reaction Questionnaire between pre and post implantation
Time Frame
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
Title
Change for STSS Subjective Tinnitus Severity Scale between pre and post implantation
Time Frame
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 Outcome Measure Information:
Title
Speech in noise intelligibility
Description
Comparison of speech intelligibility in noise with and without the speech processor, when measured in free field, with the normal hearing ear unplugged. Performance (% of words correctly repeated) is measured: With two level of noise (Speech to Noise Ratio of -3dB and +5 dB) In three different spatial configurations: (S0N0: signal and noise coming from the front; S0NIC: Signal coming from the front and noise coming from the implanted side; SICN0: Signal coming from the implanted side and noise coming from the front.
Time Frame
Before cochlear implantation, 6 and 12 after conventional stimulation
Title
Speech in quiet intelligibility with cochlear implant only
Description
Speech intelligibility for speech in quiet with the cochlear implant only (speech signals presented through direct connection).
Time Frame
6 and 12 after conventional stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Gnansia, Dr
Organizational Affiliation
Oticon Medical
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bruno Frachet, Pr
Organizational Affiliation
Hôpital Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Lille Hôpital Roger Salengro
City
Lille
Country
France
Facility Name
CHU Lyon Hôpital Edouard Herriot
City
Lyon
Country
France
Facility Name
Hôpital la Pitié Salpêtrièr
City
Paris
Country
France
Facility Name
Hôpital Rothschild
City
Paris
Country
France
Facility Name
CHU Rennes Pontchaillou
City
Rennes
Country
France
Facility Name
CHU Tours Bretonneau
City
Tours
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Tinnitus Treatment With Cochlear Implant in Single Sided Deafness

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