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Genetic Study of Age Related Hearing Loss (ARHL)

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01732289
First received: September 1, 2008
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Age-related Hearing Loss
Presbycusis
 Genetic: genes
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Genetic Study of Age Related Hearing Loss

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • which gene or Single nucleotide polymorphism is related to age related hearing loss [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Which environmental factor(s) or systemic diseases are related to age related hearing loss [ Time Frame: 2008-2009 ] [ Designated as safety issue: No ]

Enrollment: 1000
Study Start Date: August 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Genetic: genes
Draw blood for genetic screening
Other Name: no other name

  Eligibility

Ages Eligible for Study:   45 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732289

Locations
Taiwan
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
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital, Clinical professor
ClinicalTrials.gov Identifier: NCT01732289     History of Changes
Other Study ID Numbers: 200806069R, Taiwan NSC 97-2314-B-002-107
Study First Received: September 1, 2008
Last Updated: November 21, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Age-related hearing loss
Gene
Single nucleotide polymorphism
environmental factors

Additional relevant MeSH terms:
Hearing Loss
Deafness
Presbycusis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural

ClinicalTrials.gov processed this record on May 19, 2013