Tinnitus Treatment With Cochlear Implant in Single Sided Deafness
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|ClinicalTrials.gov Identifier: NCT02966366|
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Single Sided Deafness Tinnitus Cochlear Implant||Device: Cochlear implant||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tinnitus Treatment With Cochlear Implant in Single Sided Deafness|
|Actual Study Start Date :||August 27, 2013|
|Actual Primary Completion Date :||March 7, 2017|
|Actual Study Completion Date :||March 7, 2017|
Experimental: Cochlear implantation
Evaluation of tinnitus before and after cochlear implantation
Device: Cochlear implant
- 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 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 ]
- 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 ]
- 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 ]
- Speech in noise intelligibility [ Time Frame: Before cochlear implantation, 6 and 12 after conventional stimulation ]
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 [ Time Frame: 6 and 12 after conventional stimulation ]Speech intelligibility for speech in quiet with the cochlear implant only (speech signals presented through direct connection).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966366
|CHRU Lille Hôpital Roger Salengro|
|CHU Lyon Hôpital Edouard Herriot|
|Hôpital la Pitié Salpêtrièr|
|CHU Rennes Pontchaillou|
|CHU Tours Bretonneau|
|Study Director:||Dan Gnansia, Dr||Oticon Medical|
|Principal Investigator:||Bruno Frachet, Pr||Hôpital Rothschild|