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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02966366
Other study ID # PIC_02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 27, 2013
Est. completion date March 7, 2017

Study information

Verified date August 2018
Source Oticon Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date March 7, 2017
Est. primary completion date March 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
Cochlear implant


Locations

Country Name City State
France CHRU Lille Hôpital Roger Salengro Lille
France CHU Lyon Hôpital Edouard Herriot Lyon
France Hôpital la Pitié Salpêtrièr Paris
France Hôpital Rothschild Paris
France CHU Rennes Pontchaillou Rennes
France CHU Tours Bretonneau Tours

Sponsors (1)

Lead Sponsor Collaborator
Oticon Medical

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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.
Before cochlear implantation, 6 and 12 after conventional stimulation
Secondary 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). 6 and 12 after conventional stimulation
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