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临床试验/NCT01737489
NCT01737489已完成不适用

Title: "Development and Implementation of Innovative Auditory Training Methods and Verification of These Training Methods"

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2012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
发起方
Mayo Clinic
入组人数
17
试验地点
1
主要终点
Word recognition

研究概览

简要总结

The purpose of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment. Also, the study is designed to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.

详细描述

The primary objective of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment.

The secondary objective of this study is to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Criteria for Inclusion:
  • •Willingness to participate
  • •Ability to provide informed written consent
  • •Willingness to follow study protocol
  • •Eighteen years or older at the time of signing the consent form
  • •Cochlear implant experience for 12 months or greater
  • •Spoken English as the first language
  • •Access to a home computer which meets the minimal requirements to run appropriate program or the ability to use an electronic reader depending on which group the participant is assigned to.
  • •Reports being comfortable using a computer if in the LACE group
  • •Criteria for

排除标准

  • •Unable or unwillingness to sign informed written consent
  • •Unable or unwillingness to follow study protocol
  • •Non-English speaking or English as a second language
  • •No access to a computer if assigned to the LACE study group
  • •Reports not being comfortable using a computer if assigned to the LACE study group.

研究组 & 干预措施

Control

No Intervention

LACE ( Listening And Communication Enhancement )

Active Comparator

use the commercially available auditory training program which is administered by computer as daily lessons.

干预措施: LACE (Behavioral)

NOOK (Electronic reader)

Active Comparator

will use an electronic reader (NOOK device) to do speech tracking

干预措施: NOOK (Behavioral)

结局指标

主要结局

Word recognition

时间窗: baseline to 6 months

Word recognition will be measured using the Consonant Nucleus Consonant (CNC) Test, a 50 word open set test.

Signal-to-noise ratio

时间窗: baseline to 6 months

The signal to noise ratio will be measured using the Bamford-Kowal-Bench (BKB) test.

次要结局

  • Percent of speech comprehension(baseline to 6 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Annamary (Ann) Peterson

AUDIOLOGIST

Mayo Clinic

研究点 (1)

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