<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01732289</url>
  </required_header>
  <id_info>
    <org_study_id>200806069R</org_study_id>
    <secondary_id>Taiwan NSC 97-2314-B-002-107</secondary_id>
    <nct_id>NCT01732289</nct_id>
  </id_info>
  <brief_title>Genetic Study of Age Related Hearing Loss</brief_title>
  <acronym>ARHL</acronym>
  <official_title>Genetic Study of Age Related Hearing Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Age-related hearing loss, or presbyacusis, is one of the most common chronically handicapped&#xD;
      conditions for the elderly. Many factors including genetics, diet, diseases, drugs,&#xD;
      socioeconomic factors and environmental variables were considered to be related to the&#xD;
      development of presbyacusis. Evidences have shown that genetic factors play an important role&#xD;
      on presbyacusis. However, which genes or their genotypes are associated with presbycusis&#xD;
      remain unknown.&#xD;
&#xD;
      The aim of this project was to evaluate the association between the genotype of candidate&#xD;
      genes and presbyacusis by cross-section and case-control study. In the first stage, the&#xD;
      investigators plan to select 700 healthy subjects older than 50 with symmetric, sensorineural&#xD;
      hearing loss. The subjects will receive basic otologic examination, pure tone audiometry,&#xD;
      questionnaire, and genotype analysis. Because gender and age would affect hearing loss&#xD;
      significantly, The investigators will convert the hearing level of all subjects into a gender&#xD;
      and age independent Z-score according to ISO 7029 standard. And, The investigators define&#xD;
      subjects within higher 30 % of Z-score as the presbyacusis group, and subjects within lower&#xD;
      30% of Z-score as the control group. Finally, The investigators perform Chi square analysis&#xD;
      to test the association between genotype of candidate genes or their combinations in both&#xD;
      groups, and calculate the odds ratio for presbyacusis between different genotype of candidate&#xD;
      genes. Further more, we will evaluate the effect of genotype of candidate genes, environment&#xD;
      factors, and gene-environmental interaction on the severity of presbyacusis by multivariate&#xD;
      logistic regression.&#xD;
&#xD;
      In the second stage, The investigators wish to know the pattern of genotype and hearing level&#xD;
      in the high risk families, according to results from the first stage, by description and&#xD;
      case-control study. The investigators will perform t-test to evaluate the difference of&#xD;
      Z-score in both groups. Besides, The investigators try to evaluate the effects of genotypes,&#xD;
      environment factors, and gene-environmental interaction on hearing level in high risk&#xD;
      families by multivariate logistic regression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2008</start_date>
  <completion_date type="Actual">July 2009</completion_date>
  <primary_completion_date type="Actual">July 2009</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>which gene or Single nucleotide polymorphism is related to age related hearing loss</measure>
    <time_frame>2008-2009</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Which environmental factor(s) or systemic diseases are related to age related hearing loss</measure>
    <time_frame>2008-2009</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1000</enrollment>
  <condition>Age-related Hearing Loss</condition>
  <condition>Presbycusis</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>genes</intervention_name>
    <description>Draw blood for genetic screening</description>
    <arm_group_label>A</arm_group_label>
    <other_name>no other name</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects aged 45 or above, both male and female came to the hospital for health check&#xD;
             up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known ontological disease age under 45 noise exposure history history of ototoxicity&#xD;
             psychiatric diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tien-Chen Liu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Otolayrngology, National Taiwan Univserity Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwna University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 1, 2008</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>November 21, 2012</last_update_submitted>
  <last_update_submitted_qc>November 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
    <investigator_full_name>National Taiwan University Hospital</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <keyword>Age-related hearing loss</keyword>
  <keyword>Gene</keyword>
  <keyword>Single nucleotide polymorphism</keyword>
  <keyword>environmental factors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Presbycusis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01732289
org study id: 200806069R
secondary id: Taiwan NSC 97-2314-B-002-107
nct id: NCT01732289
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: which gene or Single nucleotide polymorphism is related to age related hearing loss
time frame: 2008-2009
measure: Which environmental factor(s) or systemic diseases are related to age related hearing loss
time frame: 2008-2009
arm group label: A
arm group type: Experimental
intervention type: Genetic
intervention name: genes
description: Draw blood for genetic screening
arm group label: A
other name: no other name
criteria: 
gender: All
minimum age: 45 Months
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tien-Chen Liu, MD, PhD
role: Principal Investigator
affiliation: Department of Otolayrngology, National Taiwan Univserity Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University Hospital
investigator full name: National Taiwan University Hospital
investigator title: Clinical professor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Presbycusis