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Thai-version Five Minute Hearing Test (Thai_FMHT)

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Audiometry
Thai-Five Minute Hearing Test
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hearing Loss focused on measuring Hearing screening, Questionnaire, Hearing disability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years old or older

Exclusion Criteria:

  • having aphasia, or severe mental disability, or other conditions which can not accommodate audiometry.

Sites / Locations

  • Phu Weng

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FMHT

Arm Description

All community people will be interviewed with Thai Five Minute Hearing Test questionnaire and will be tested with an audiometry.

Outcomes

Primary Outcome Measures

Standard Hearing Test
Hearing loss is defined as an elevation, at least more than 25 dB of air-conduction, pure tone average threshold at speech frequencies. The severity loss is categorized into mild (26-40 dB), moderate (41-55 dB), moderately severe (56-74 dB), severe (75-90 dB), and profound (>90 dB). In this study, we aim to use FMHT as a screening tool for hearing disability (Better hearing ear has hearing threshold greater than 40 dB).

Secondary Outcome Measures

Prevalence of Ear Diseases
the frequency of diseased ears per the total examined ears

Full Information

First Posted
August 1, 2011
Last Updated
April 17, 2014
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT01408992
Brief Title
Thai-version Five Minute Hearing Test
Acronym
Thai_FMHT
Official Title
The Evaluation of Thai-version Five Minute Hearing Test to Screen Hearing in Community
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is aimed to test the sensitivity and specificity of Thai-version Five Minutes Hearing test against the audiometry to screen hearing problem in community.
Detailed Description
Study Population Phu Wieng district, Khon Kaen Province was chose to be a represent of rural community in Thailand. 551 subjects were desired to cover 80% sensitivity of the original test, at 95% confidence level, 80% power, and 7% margin of error. Regarding to 22.7% of the estimated prevalence of hearing loss and 10% drop out rate, then the total subjects need was 606 persons. Subjects were divided to recruit from simple random villages, one from the municipal and the other from non-municipal area. All people in target villages whether having ear problem or not, who was older than 18 years old, could read or understand Thai language, and wanted to participate, were persuaded. Those who had aphasia, or severe mental disability, or other conditions that could not perform audiometry were excluded. Study Procedure After consenting to participate, subjects were interviewed with Thai-FMHT. Then the subjects were undergone the audiometry in the soundproof booth performed by audiologists who were blinded the result of Thai-FMHT. Pure tone threshold at 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hz of both ears were recorded. Tympanogram was done to confirm middle ear pathology. Any pure tone air-conduction threshold greater than 25 dB in one or two frequencies was considered as abnormal hearing. However, the severity of hearing loss was defined by pure tone average air-conduction threshold according to ASHA criteria. To compare with the original FMHT, the pure tone average air-conduction threshold at 500, 1000, and 2000 Hz was defined as speech PTA (SF-PTA), whereas, the pure tone average air-conduction threshold at 3000, 4000, 6000, 8000 Hz was defined as high frequency PTA (HF-PTA). Hearing disability was classified according to the hearing level of the better hearing ear. Otolaryngologists did history taking. Ear symptoms such as otalgia, itching, otorrhea, tinnitus, and hearing loss was asked before performing otoscopy and making a final diagnosis. The treatment, or medication if needed, and advice were complementary provided to subjects as post-trial benefits. Statistical analysis Descriptive analysis was used to present demographic data. The sensitivity, specificity, and ROC were analyzed using STATA software version 10.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Hearing screening, Questionnaire, Hearing disability

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
N/A
Enrollment
558 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMHT
Arm Type
Experimental
Arm Description
All community people will be interviewed with Thai Five Minute Hearing Test questionnaire and will be tested with an audiometry.
Intervention Type
Procedure
Intervention Name(s)
Audiometry
Intervention Description
Standard hearing test performed by audiologists
Intervention Type
Other
Intervention Name(s)
Thai-Five Minute Hearing Test
Intervention Description
All subjects will be interviewed with Thai-Five Minute Hearing Test
Primary Outcome Measure Information:
Title
Standard Hearing Test
Description
Hearing loss is defined as an elevation, at least more than 25 dB of air-conduction, pure tone average threshold at speech frequencies. The severity loss is categorized into mild (26-40 dB), moderate (41-55 dB), moderately severe (56-74 dB), severe (75-90 dB), and profound (>90 dB). In this study, we aim to use FMHT as a screening tool for hearing disability (Better hearing ear has hearing threshold greater than 40 dB).
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Prevalence of Ear Diseases
Description
the frequency of diseased ears per the total examined ears
Time Frame
Immediate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years old or older Exclusion Criteria: having aphasia, or severe mental disability, or other conditions which can not accommodate audiometry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwanchanok Yimtae, M.D.
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pornthep Kasemsiri, M.D.
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Panida Thanawirattananit, M.A.
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phu Weng
City
Ban Phu Wang
State/Province
Khon Kaen
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
24457423
Citation
Yimtae K, Kasemsiri P, Thanawirattananit P, Siripaopradith P. Validation of the Thai five-minute hearing test to screen hearing loss in the community. Audiol Neurootol. 2014;19(2):127-34. doi: 10.1159/000357492. Epub 2014 Jan 22.
Results Reference
derived

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Thai-version Five Minute Hearing Test

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