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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01732289
Other study ID # 200806069R
Secondary ID Taiwan NSC 97-23
Status Completed
Phase Phase 0
First received September 1, 2008
Last updated November 21, 2012
Start date August 2008
Est. completion date July 2009

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Genetic:
genes
Draw blood for genetic screening

Locations

Country Name City State
Taiwan National Taiwna University Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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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