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Genetic Study of Age Related Hearing Loss (ARHL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01732289
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : November 22, 2012
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

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
Age-related Hearing Loss Presbycusis Genetic: genes Early Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : August 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: A Genetic: genes
Draw blood for genetic screening
Other Name: no other name

Primary Outcome Measures :
  1. which gene or Single nucleotide polymorphism is related to age related hearing loss [ Time Frame: 2008-2009 ]

Secondary Outcome Measures :
  1. Which environmental factor(s) or systemic diseases are related to age related hearing loss [ Time Frame: 2008-2009 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Months and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01732289

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National Taiwna University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
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Principal Investigator: Tien-Chen Liu, MD, PhD Department of Otolayrngology, National Taiwan Univserity Hospital
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Responsible Party: National Taiwan University Hospital, Clinical professor Identifier: NCT01732289    
Other Study ID Numbers: 200806069R
Taiwan NSC 97-2314-B-002-107
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: November 22, 2012
Last Verified: November 2012
Keywords provided by National Taiwan University Hospital:
Age-related hearing loss
Single nucleotide polymorphism
environmental factors
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Hearing Loss, Sensorineural