跳至主要内容
临床试验/NCT02966366
NCT02966366已完成不适用

Tinnitus Treatment With Cochlear Implant in Single Sided Deafness

Oticon Medical6 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2013年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
6
主要终点
Change for TRQ Tinnitus Reaction Questionnaire between pre and post implantation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change for TRQ Tinnitus Reaction Questionnaire between pre and post implantation

时间窗: 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 THI Tinnitus Handicap Inventory scale between pre and post implantation

时间窗: 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 Visual Analog Scale (VAS) on Intensity and annoyance between pre and post implantation

时间窗: 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 STSS Subjective Tinnitus Severity Scale between pre and post implantation

时间窗: 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

次要结局

  • Speech in noise intelligibility(Before cochlear implantation, 6 and 12 after conventional stimulation)
  • Speech in quiet intelligibility with cochlear implant only(6 and 12 after conventional stimulation)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验