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临床试验/NCT01732289
NCT01732289已完成早期 1 期

Genetic Study of Age Related Hearing Loss

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
1,000
试验地点
1
主要终点
which gene or Single nucleotide polymorphism is related to age related hearing loss

研究概览

简要总结

Age-related hearing loss, or presbyacusis, is one of the most common chronically handicapped conditions for the elderly. Many factors including genetics, diet, diseases, drugs, socioeconomic factors and environmental variables were considered to be related to the development of presbyacusis. Evidences have shown that genetic factors play an important role on presbyacusis. However, which genes or their genotypes are associated with presbycusis remain unknown.

The aim of this project was to evaluate the association between the genotype of candidate genes and presbyacusis by cross-section and case-control study. In the first stage, the investigators plan to select 700 healthy subjects older than 50 with symmetric, sensorineural hearing loss. The subjects will receive basic otologic examination, pure tone audiometry, questionnaire, and genotype analysis. Because gender and age would affect hearing loss significantly, The investigators will convert the hearing level of all subjects into a gender and age independent Z-score according to ISO 7029 standard. And, The investigators define subjects within higher 30 % of Z-score as the presbyacusis group, and subjects within lower 30% of Z-score as the control group. Finally, The investigators perform Chi square analysis to test the association between genotype of candidate genes or their combinations in both groups, and calculate the odds ratio for presbyacusis between different genotype of candidate genes. Further more, we will evaluate the effect of genotype of candidate genes, environment factors, and gene-environmental interaction on the severity of presbyacusis by multivariate logistic regression.

In the second stage, The investigators wish to know the pattern of genotype and hearing level in the high risk families, according to results from the first stage, by description and case-control study. The investigators will perform t-test to evaluate the difference of Z-score in both groups. Besides, The investigators try to evaluate the effects of genotypes, environment factors, and gene-environmental interaction on hearing level in high risk families by multivariate logistic regression.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
45 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects aged 45 or above, both male and female came to the hospital for health check up

排除标准

  • known ontological disease age under 45 noise exposure history history of ototoxicity psychiatric diseases

结局指标

主要结局

which gene or Single nucleotide polymorphism is related to age related hearing loss

时间窗: 2008-2009

次要结局

  • Which environmental factor(s) or systemic diseases are related to age related hearing loss(2008-2009)

研究者

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

National Taiwan University Hospital

Clinical professor

National Taiwan University Hospital

研究点 (1)

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