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临床试验/NCT01408992
NCT01408992已完成不适用

The Evaluation of Thai-version Five Minute Hearing Test to Screen Hearing in Community

Khon Kaen University1 个研究点 分布在 1 个国家目标入组 558 人开始时间: 2011年7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
558
试验地点
1
主要终点
Standard Hearing Test

研究概览

简要总结

This study is aimed to test the sensitivity and specificity of Thai-version Five Minutes Hearing test against the audiometry to screen hearing problem in community.

详细描述

Study Population Phu Wieng district, Khon Kaen Province was chose to be a represent of rural community in Thailand. 551 subjects were desired to cover 80% sensitivity of the original test, at 95% confidence level, 80% power, and 7% margin of error. Regarding to 22.7% of the estimated prevalence of hearing loss and 10% drop out rate, then the total subjects need was 606 persons. Subjects were divided to recruit from simple random villages, one from the municipal and the other from non-municipal area. All people in target villages whether having ear problem or not, who was older than 18 years old, could read or understand Thai language, and wanted to participate, were persuaded. Those who had aphasia, or severe mental disability, or other conditions that could not perform audiometry were excluded.

Study Procedure After consenting to participate, subjects were interviewed with Thai-FMHT. Then the subjects were undergone the audiometry in the soundproof booth performed by audiologists who were blinded the result of Thai-FMHT. Pure tone threshold at 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hz of both ears were recorded. Tympanogram was done to confirm middle ear pathology. Any pure tone air-conduction threshold greater than 25 dB in one or two frequencies was considered as abnormal hearing. However, the severity of hearing loss was defined by pure tone average air-conduction threshold according to ASHA criteria. To compare with the original FMHT, the pure tone average air-conduction threshold at 500, 1000, and 2000 Hz was defined as speech PTA (SF-PTA), whereas, the pure tone average air-conduction threshold at 3000, 4000, 6000, 8000 Hz was defined as high frequency PTA (HF-PTA). Hearing disability was classified according to the hearing level of the better hearing ear.

Otolaryngologists did history taking. Ear symptoms such as otalgia, itching, otorrhea, tinnitus, and hearing loss was asked before performing otoscopy and making a final diagnosis. The treatment, or medication if needed, and advice were complementary provided to subjects as post-trial benefits.

Statistical analysis Descriptive analysis was used to present demographic data. The sensitivity, specificity, and ROC were analyzed using STATA software version 10.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •18 years old or older

排除标准

  • •having aphasia, or severe mental disability, or other conditions which can not accommodate audiometry.

研究组 & 干预措施

FMHT

Experimental

All community people will be interviewed with Thai Five Minute Hearing Test questionnaire and will be tested with an audiometry.

干预措施: Audiometry (Procedure)

FMHT

Experimental

All community people will be interviewed with Thai Five Minute Hearing Test questionnaire and will be tested with an audiometry.

干预措施: Thai-Five Minute Hearing Test (Other)

结局指标

主要结局

Standard Hearing Test

时间窗: Baseline

Hearing loss is defined as an elevation, at least more than 25 dB of air-conduction, pure tone average threshold at speech frequencies. The severity loss is categorized into mild (26-40 dB), moderate (41-55 dB), moderately severe (56-74 dB), severe (75-90 dB), and profound (\>90 dB). In this study, we aim to use FMHT as a screening tool for hearing disability (Better hearing ear has hearing threshold greater than 40 dB).

次要结局

  • Prevalence of Ear Diseases(Immediate)

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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