Presbycusis Clinical Trial
— ARHLOfficial title:
Genetic Study of Age Related Hearing Loss
Verified date | November 2012 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1000 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 45 Months and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwna University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | which gene or Single nucleotide polymorphism is related to age related hearing loss | 2008-2009 | No | |
Secondary | Which environmental factor(s) or systemic diseases are related to age related hearing loss | 2008-2009 | No |
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