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Genetic Study of Age Related Hearing Loss

NCT ID: NCT01732289

Last Updated: 2012-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age-related Hearing Loss Presbycusis

Keywords

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Age-related hearing loss Gene Single nucleotide polymorphism environmental factors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Group Type EXPERIMENTAL

genes

Intervention Type GENETIC

Draw blood for genetic screening

Interventions

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genes

Draw blood for genetic screening

Intervention Type GENETIC

Other Intervention Names

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no other name

Eligibility Criteria

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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
Minimum Eligible Age

45 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tien-Chen Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Otolayrngology, National Taiwan Univserity Hospital

Locations

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National Taiwna University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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Taiwan NSC 97-2314-B-002-107

Identifier Type: -

Identifier Source: secondary_id

200806069R

Identifier Type: -

Identifier Source: org_study_id