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Genetic Study of Age Related Hearing Loss (ARHL)

Primary Purpose

Age-related Hearing Loss, Presbycusis

Status
Completed
Phase
Early Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
genes
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Age-related Hearing Loss focused on measuring Age-related hearing loss, Gene, Single nucleotide polymorphism, environmental factors

Eligibility Criteria

45 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Taiwna University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 1, 2008
Last Updated
November 21, 2012
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01732289
Brief Title
Genetic Study of Age Related Hearing Loss
Acronym
ARHL
Official Title
Genetic Study of Age Related Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Hearing Loss, Presbycusis
Keywords
Age-related hearing loss, Gene, Single nucleotide polymorphism, environmental factors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Genetic
Intervention Name(s)
genes
Other Intervention Name(s)
no other name
Intervention Description
Draw blood for genetic screening
Primary Outcome Measure Information:
Title
which gene or Single nucleotide polymorphism is related to age related hearing loss
Time Frame
2008-2009
Secondary Outcome Measure Information:
Title
Which environmental factor(s) or systemic diseases are related to age related hearing loss
Time Frame
2008-2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tien-Chen Liu, MD, PhD
Organizational Affiliation
Department of Otolayrngology, National Taiwan Univserity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwna University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Genetic Study of Age Related Hearing Loss

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