ARHL: Genetic Study of Age Related Hearing Loss

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01732289
Collaborator
National Science Council, Taiwan (Other)
1,000
1
1
11
91.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: genes
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
1000 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
Genetic Study of Age Related Hearing Loss
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Genetic: genes
Draw blood for genetic screening
Other Names:
  • no other name
  • Outcome Measures

    Primary Outcome Measures

    1. which gene or Single nucleotide polymorphism is related to age related hearing loss [2008-2009]

    Secondary Outcome Measures

    1. Which environmental factor(s) or systemic diseases are related to age related hearing loss [2008-2009]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Months and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwna University Hospital Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital
    • National Science Council, Taiwan

    Investigators

    • Principal Investigator: Tien-Chen Liu, MD, PhD, Department of Otolayrngology, National Taiwan Univserity Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital, Clinical professor, National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT01732289
    Other Study ID Numbers:
    • 200806069R
    • Taiwan NSC 97-2314-B-002-107
    First Posted:
    Nov 22, 2012
    Last Update Posted:
    Nov 22, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by National Taiwan University Hospital, Clinical professor, National Taiwan University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 22, 2012