Clinical trial NCT01732289: Genetic Study of Age Related Hearing Loss
Official title: Genetic Study of Age Related Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Age-related Hearing Loss
Presbycusis
Keywords: Age-related hearing loss
Gene
Single nucleotide polymorphism
environmental factors
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2012-11-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 45
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: which gene or Single nucleotide polymorphism is related to age related hearing loss
timeFrame: 2008-2009
Secondary outcomes:
measure: Which environmental factor(s) or systemic diseases are related to age related hearing loss
timeFrame: 2008-2009
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwna University Hospital
Study officials:
affiliation: Department of Otolayrngology, National Taiwan Univserity Hospital
name: Tien-Chen Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: