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临床试验/NCT02204618
NCT02204618已完成不适用

Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
2
主要终点
incremental cost-utility ratio

研究概览

简要总结

The investigators assume that cochlear implants in this indication are not only effective but also cost-effective. The investigators' experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A comparative cost-utility analysis between the two arms, of medical consequences measured in terms of quality of life will identify a preference for a strategy. Specific binaural hearing measurements with respect to each treatment option (abstention, CROS, bone conduction device, cochlear implant) will also be collected.

详细描述

Single sided deafness and profound asymmetrical hearing loss are impairments that significantly alter quality of life. Behavioural problems and scholar delays have been reported in children. Speech recognition with background or competing noise and sound localization are both impaired. 1/1000 new borns are affected and the incidence tends to rise in the adult population. At the moment, there is no guideline regarding the treatment of single sided deafness and asymmetrical hearing loss. Some patients don't even receive any therapeutic proposition.

Three treatment options are available :

  • CROS (Contralateral Routing Of the Signal) systems that convey the auditory information from the deaf ear to the good ear using wi-fi
  • bone conduction devices which use transcranial conduction to convey auditory information from the poor ear to the good ear
  • cochlear implants that directly stimulate afferent fibers of auditory nerve in the poor ear Cochlear implantation is therefore the only treatment which restores stimulation in the poor ear. Its efficacy in single sided deafness associated with incapacitating tinnitus have been demonstrated by Pr Van de Heyning (Leeuven, Be) and colleagues. Its interest has been compared to CROS systems and bone conduction devices in a valuable study conducted by S. Arndt (Pr Laszig, Freibourg, Ger). Cochlear implants provided better speech in noise recognition scores in dichotic hearing, i.e when speech and noise sources are spatially separated. Their first publication involved 11 patients but to date, more than 110 patients with single sided deafness have been included in their protocol. The efficacy of cochlear implantation has thus been validated in the treatment of single sided deafness and asymmetrical hearing loss.

The investigators assume that cochlear implants in this indication are not only effective but also cost-effective. The investigators' experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A comparative cost-utility analysis between the two arms, of medical consequences measured in terms of quality of life will identify a preference for a strategy. Specific binaural hearing measurements with respect to each treatment option (abstention, CROS, bone conduction device, cochlear implant) will also be collected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Social security affiliation
  • Single sided deafness or profound asymmetrical hearing loss confirmed using pure tone audiometry and auditory brainstem responses, with or without tinnitus
  • Written consent to the protocol

排除标准

  • Retrocochlear pathology (vestibular schwannoma, severe central auditory processing disorder)
  • Major cochlear ossification or malformation
  • Subjects under juridical protections or tutelage measure

研究组 & 干预措施

cochlear implantation

Experimental

Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).

干预措施: cochlear implantation (Device)

6 months initial abstention

Other

Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).

干预措施: 6 months initial abstention (Other)

结局指标

主要结局

incremental cost-utility ratio

时间窗: 6 months after cochlear implantation versus no treatment option

次要结局

  • Global score of EuroQoL-5D(before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6)
  • Global score of Nijmegen Cochlear implant Questionnaire (NCIQ)(before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6)
  • Nijmegen Cochlear Implant Questionnaire (NCIQ): score in advanced auditory perception section(before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6)
  • Speech Reception Thresholds(before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6)
  • Mean error angle for sound localization(before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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