Thai-version Five Minute Hearing Test (Thai_FMHT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kwanchanok Yimtae, M.D., Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01408992
First received: August 1, 2011
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Hearing Loss
Procedure: Audiometry
Other: Thai-Five Minute Hearing Test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Evaluation of Thai-version Five Minute Hearing Test to Screen Hearing in Community

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Standard Hearing Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Immediate ] [ Designated as safety issue: No ]
    the frequency of diseased ears per the total examined ears


Enrollment: 558
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FMHT
All community people will be interviewed with Thai Five Minute Hearing Test questionnaire and will be tested with an audiometry.
Procedure: Audiometry
Standard hearing test performed by audiologists
Other: Thai-Five Minute Hearing Test
All subjects will be interviewed with Thai-Five Minute Hearing Test

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years old or older

Exclusion Criteria:

  • having aphasia, or severe mental disability, or other conditions which can not accommodate audiometry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408992

Locations
Thailand
Phu Weng
Ban Phu Wang, Khon Kaen, Thailand
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Kwanchanok Yimtae, M.D. Khon Kaen University
Principal Investigator: Pornthep Kasemsiri, M.D. Khon Kaen University
Principal Investigator: Panida Thanawirattananit, M.A. Khon Kaen University
  More Information

No publications provided

Responsible Party: Kwanchanok Yimtae, M.D., Assoc. Prof. Kwanchanok Yimtae, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01408992     History of Changes
Other Study ID Numbers: HE541135
Study First Received: August 1, 2011
Results First Received: December 29, 2011
Last Updated: April 17, 2014
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
Hearing screening
Questionnaire
Hearing disability

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

ClinicalTrials.gov processed this record on October 23, 2014