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临床试验/NCT01902914
NCT01902914Unknown1 期

Effectiveness of NECTEC Model, Body-worn, Digital Hearing Aids and Cost of Screening and Hearing Aids Service in Elders

Khon Kaen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
1 期
入组人数
100
试验地点
1
主要终点
functional gain

研究概览

简要总结

To test the effectiveness of body-worn, digital hearing aids, model 02 which is developed by the National Electronics and Computer Technology Center, Thailand.

详细描述

Hearing aids distribution and service system are limited accessed in hearing disabled people in developing countries. The local-made, body-worn, digital hearing aids is developed by the National Electronics and Computer Technology Center, Thailand. The effectiveness of this model will be compares with other standard body-worn, hearing aids in community elders. The functional gain, quality of sound, customers' satisfaction, and quality of life (EQ-5D, HHIE, HUI-3, IOI-HA) are main outcomes.The cost of Screening and hearing aids will be also investigated. The validity and reliability of several tools used such as the Thai-Hearing Handicap Inventory for elderly (HHIE) questionnaire, Music Test, Thai-Five Minute Hearing Test, and Khon Kaen Hearing Aids Evaluation are also studied.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • older than 60 years
  • bilateral sensorineural hearing loss
  • PTA (0.5-2 KHz) of better ear > 40 DB but <75 dB
  • no deformity of pinna and ear canal
  • new or unexperienced hearing aids user
  • can communicate with Thai or local language

排除标准

  • speech discrimination <40%
  • suspected of retrocochlear lesion

结局指标

主要结局

functional gain

时间窗: Immediate after hearing aids fitting

Different of hearing threshold between aids and un-aids

次要结局

  • Satisfaction(immediate after hearing aids fitting)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kwanchanok Yimtae, M.D.

Assoc. Prof. Kwanchanok Yimtae

Khon Kaen University

研究点 (1)

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