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临床试验/NCT05736055
NCT05736055Enrolling By Invitation不适用

Validation Of Cambodia Version of Five Minutes Hearing Test to Screening Hearing Loss

Khon Kaen University1 个研究点 分布在 1 个国家目标入组 481 人开始时间: 2023年3月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
481
试验地点
1
主要终点
sensitivity of the questionnaire (FMHT in Cambodia version (CAM-FMHT))
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Seek the simple tool as questionnaire for screening hearing loss. The FMHT was developed by American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). It is a standard hearing questionnaire. So, we plan to translate the FMHT into Cambodian language and validate by comparing its result with those of audiometry.

详细描述

Primary Objective:

To assess sensitivity of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry

Secondary Objective: To assess

  1. Specificity of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry
  2. Likelihood ratio of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry
  3. Predictive value of the FMHT in Cambodia version (CAM-FMHT) compared with the standard audiometry

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years（Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-60 years old
  • •Able to read and understand Khmer language
  • •Volunteer to participated

排除标准

  • •Aphasia patients
  • •Patients with severe mental disability
  • •Patients with other conditions that preclude audiometry

结局指标

主要结局

sensitivity of the questionnaire (FMHT in Cambodia version (CAM-FMHT))

时间窗: 2 years

The questionnaire will be used to measure the outcome (score 0 (better outcome)-score45 (worse outcome))

次要结局

  • likelihood ratio of the questionnaire (FMHT in Cambodia version (CAM-FMHT))(2 years)
  • predictive value of the questionnaire (FMHT in Cambodia version (CAM-FMHT))(2 years)
  • specificity of the questionnnaire (FMHT in Cambodia version (CAM-FMHT))(2 years)

研究者

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

Dawin Rotha, MD

Principal Investigator

Khon Kaen University

研究点 (1)

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