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Clinical Trials/NCT01732289
NCT01732289
Completed
Early Phase 1

Genetic Study of Age Related Hearing Loss

National Taiwan University Hospital1 site in 1 country1,000 target enrollmentAugust 2008

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Age-related Hearing Loss
Sponsor
National Taiwan University Hospital
Enrollment
1000
Locations
1
Primary Endpoint
which gene or Single nucleotide polymorphism is related to age related hearing loss
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
July 2009
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

National Taiwan University Hospital

Clinical professor

National Taiwan University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 2008-2009

Secondary Outcomes

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

Study Sites (1)

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