Genetic Study of Age Related Hearing Loss

NCT01732289 | Completed Early Phase 1 DMC

• 2 other identifiers: 200806069RTaiwan NSC 97-2314-B-002-107
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Hearing Loss; Presbycusis

Keywords

Age-related hearing loss; Gene; Single nucleotide polymorphism; environmental factors

Outcome Measures

Primary Outcomes (1)

• which gene or Single nucleotide polymorphism is related to age related hearing loss

  2008-2009

Secondary Outcomes (1)

• Which environmental factor(s) or systemic diseases are related to age related hearing loss

  2008-2009

Study Arms (1)

A

EXPERIMENTAL

Genetic: genes

Interventions

genes GENETIC

Draw blood for genetic screening

Also known as: no other name

A

Eligibility Criteria

• Age: 45 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects aged 45 or above, both male and female came to the hospital for health check up

You may not qualify if:

• known ontological disease age under 45 noise exposure history history of ototoxicity psychiatric diseases

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwna University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Presbycusis

Interventions

Genes

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genome Components; Genome; Genetic Structures; Genetic Phenomena

Study Officials

• Tien-Chen Liu, MD, PhD

  Department of Otolayrngology, National Taiwan Univserity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: September 1, 2008
• First Posted: November 22, 2012
• Study Start: August 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: November 22, 2012

Record last verified: 2012-11

Locations

TW (1)