Tinnitus Clinical Trial
Official title:
Tinnitus Treatment With Cochlear Implant in Single Sided Deafness
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 |
Verified date | August 2018 |
Source | Oticon Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Oticon Medical |
France,
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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