- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02966366
Tinnitus Treatment With Cochlear Implant in Single Sided Deafness
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Lille, France
- CHRU Lille Hôpital Roger Salengro
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Lyon, France
- CHU Lyon Hôpital Edouard Herriot
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Paris, France
- Hôpital la Pitié Salpêtrièr
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Paris, France
- Hôpital Rothschild
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Rennes, France
- CHU Rennes Pontchaillou
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Tours, France
- CHU Tours Bretonneau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cochlear implantation
Evaluation of tinnitus before and after cochlear implantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
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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
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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
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
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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
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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
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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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech in noise intelligibility
Time Frame: Before cochlear implantation, 6 and 12 after conventional stimulation
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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:
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Before cochlear implantation, 6 and 12 after conventional stimulation
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Speech in quiet intelligibility with cochlear implant only
Time Frame: 6 and 12 after conventional stimulation
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Speech intelligibility for speech in quiet with the cochlear implant only (speech signals presented through direct connection).
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6 and 12 after conventional stimulation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bruno Frachet, Pr, Hôpital Rothschild
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIC_02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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