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临床试验/CTRI/2024/04/065271
CTRI/2024/04/065271尚未招募不适用

Development and validation of aural rehabilitation module for adults with hearing loss and their significant others

Spoorthi G N1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
1. Hearing related quality of life

研究概览

简要总结

The aim of the study is to develop a short-term aural rehabilitation module for adults with hearing loss and their significant others in Kannada and validate it. The objectives are to

1.     (1) To develop a short-term aural rehabilitation module in Kannada for adults with acquired hearing loss and their significant others.

2.     (2) To validate the developed aural rehabilitation module in Kannada for adults with acquired hearing loss and their significant others.

It is hypothesized that the developed aural rehabilitation module will improve various aspects of quality of life of individuals with hearing loss and their significant others.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Kannada speaking individuals with acquired bilateral hearing loss [four frequency pure tone average (500Hz, 1000Hz, 2000Hz and 4000Hz) between 26 dB HL and 90 dB HL] within the age of
  • At least “good” proficiency in Language Experience and Proficiency Questionnaire (LEAP-Q) for reading and speaking proficiency in Kannada
  • Individuals with sensorineural or mixed hearing loss
  • Speech identification scores proportional to pure tone audiometry
  • Aided audiogram at least three frequencies within speech spectrum
  • At least threesix months of experience in using hearing aids, preferably unilateral
  • Self-reported hearing aid use of 4-6 hours daily
  • Montreal Cognitive Assessment (MoCA) scores between 23 to 26.

排除标准

  • Individuals with congenital hearing loss, unilateral hearing loss, conductive hearing loss, or profound degree of hearing loss
  • Individuals who cannot read properly due to vision problems.

结局指标

主要结局

1. Hearing related quality of life

时间窗: Baseline, two weeks post rehabilitation, two months post rehabilitation

2. General quality of life

时间窗: Baseline, two weeks post rehabilitation, two months post rehabilitation

3. Communication profile

时间窗: Baseline, two weeks post rehabilitation, two months post rehabilitation

4. Listening effort

时间窗: Baseline, two weeks post rehabilitation, two months post rehabilitation

5. ICF activity and participation domains

时间窗: Baseline, two weeks post rehabilitation, two months post rehabilitation

6. General fatigue

时间窗: Baseline, two weeks post rehabilitation, two months post rehabilitation

次要结局

  • Listening effort(Baseline, two weeks post rehabilitation, two months post rehabilitation)

研究者

发起方
Spoorthi G N
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Spoorthi G N

Kasturba Medical College, Mangalore

研究点 (1)

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